WorldWideScience

Sample records for oncology trials consortium

  1. The creation of the Comparative Oncology Trials Consortium Pharmacodynamic Core: Infrastructure for a virtual laboratory.

    Science.gov (United States)

    Paoloni, Melissa; Lana, Susan; Thamm, Douglas; Mazcko, Christina; Withrow, Stephen

    2010-07-01

    The National Cancer Institute-Comparative Oncology Trials Consortium (NCI-COTC) aims to inform the development path of novel drugs and biologicals for human cancer patients through their evaluation in dogs with neoplasia. The advent of sophisticated clinical trials in veterinary medicine requires additional infrastructure to evaluate tissue and fluid end-points vital to questions relating to drug activity, targeting and toxicity. Pharmacokinetic and pharmacodynamic end-points necessitate a centralized laboratory for quality controlled assay development and execution. Establishing the COTC Pharmacodynamic Core (PD Core) has addressed the need for uniform end-point analysis by serving as a virtual laboratory that capitalizes on the expertise of the COTC community of investigators. Veterinary biomarker validation is a secondary benefit of these efforts. The PD Core exemplifies the construction of a successful infrastructure within the veterinary research community in line with advances in technology and focused on improving the health and quality of life of both human and animal cancer patients.

  2. Importance of dose intensity in neuro-oncology clinical trials: summary report of the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium.

    OpenAIRE

    2001-01-01

    Therapeutic options for the treatment of malignant brain tumors have been limited, in part, because of the presence of the blood-brain barrier. For this reason, the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium, the focus of which was the "Importance of Dose Intensity in Neuro-Oncology Clinical Trials," was convened in April 2000, at Government Camp, Mount Hood, Oregon. This meeting, which was supported by the National Cancer Institute, the National Institute of Neurol...

  3. Importance of dose intensity in neuro-oncology clinical trials: summary report of the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium.

    Science.gov (United States)

    Doolittle, N D; Anderson, C P; Bleyer, W A; Cairncross, J G; Cloughesy, T; Eck, S L; Guastadisegni, P; Hall, W A; Muldoon, L L; Patel, S J; Peereboom, D; Siegal, T; Neuwelt, E A

    2001-01-01

    Therapeutic options for the treatment of malignant brain tumors have been limited, in part, because of the presence of the blood-brain barrier. For this reason, the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium, the focus of which was the "Importance of Dose Intensity in Neuro-Oncology Clinical Trials," was convened in April 2000, at Government Camp, Mount Hood, Oregon. This meeting, which was supported by the National Cancer Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute of Deafness and Other Communication Disorders, brought together clinicians and basic scientists from across the U.S. to discuss the role of dose intensity and enhanced chemotherapy delivery in the treatment of malignant brain tumors and to design multicenter clinical trials. Optimizing chemotherapy delivery to the CNS is crucial, particularly in view of recent progress identifying certain brain tumors as chemosensitive. The discovery that specific constellations of genetic alterations can predict which tumors are chemoresponsive, and can therefore more accurately predict prognosis, has important implications for delivery of intensive, effective chemotherapy regimens with acceptable toxicities. This report summarizes the discussions, future directions, and key questions regarding dose-intensive treatment of primary CNS lymphoma, CNS relapse of systemic non-Hodgkin's lymphoma, anaplastic oligodendroglioma, high-grade glioma, and metastatic cancer of the brain. The promising role of cytoenhancers and chemoprotectants as part of dose-intensive regimens for chemosensitive brain tumors and development of improved gene therapies for malignant gliomas are discussed.

  4. Pharmacokinetic and pharmacodynamic study of doxorubicin in children with cancer: results of a "European Pediatric Oncology Off-patents Medicines Consortium" trial.

    Science.gov (United States)

    Krischke, Miriam; Hempel, Georg; Völler, Swantje; André, Nicolas; D'Incalci, Maurizio; Bisogno, Gianni; Köpcke, Wolfgang; Borowski, Matthias; Herold, Ralf; Boddy, Alan V; Boos, Joachim

    2016-12-01

    Doxorubicin is a key component in many pediatric oncology treatment regimens; still pharmacology data on which current dosing regimens are based are very limited. We conducted a multinational pharmacokinetic study investigating age dependency of doxorubicin metabolism and elimination in children with cancer. One hundred and one patients treated with doxorubicin according to a cancer-specific national or European therapeutic trial were recruited. Doses of doxorubicin ranged from 10.4 to 57.7 mg/m(2). Blood samples for measurement of doxorubicin and its metabolite doxorubicinol were collected after two administrations, with five samples collected in children doxorubicin clearance was demonstrated, with children less than 3 years having a statistically significant lower clearance (21.1 ± 5.8 l/h/m(2)) than older children (26.6 ± 6.7 l/h/m(2)) (p = 0.0004) after correcting for body surface area. No effect of the investigated genetic polymorphisms on the pharmacokinetics could be observed. Although natriuretic peptides were transiently elevated after each doxorubicin administration and troponin levels increased with increasing doxorubicin exposure, only limited correlation could be observed between their blood levels and doxorubicin pharmacokinetics. In the European framework of funding and regulatory support, an add-on study to existing therapeutic trials was developed. The pediatric need concerning missing PK data could be addressed with limited burden for the patients. Empirically used dose adaptations for infants were generally found to be justified based on our PK analyses.

  5. Lessons Learned from Radiation Oncology Clinical Trials

    OpenAIRE

    Liu, Fei-Fei; Okunieff, Paul; Bernhard, Eric J.; Stone, Helen B.; Yoo, Stephen; Coleman, C. Norman; Vikram, Bhadrasain; Brown, Martin; Buatti, John; Guha, Chandan

    2013-01-01

    A Workshop entitled “Lessons Learned from Radiation Oncology Trials” was held on December 7–8th, 2011 in Bethesda, MD, to present and discuss some of the recently conducted Radiation Oncology clinical trials with a focus on those that failed to refute the null hypothesis. The objectives of this Workshop were to summarize and examine the questions that these trials provoked, to assess the quality and limitations of the pre-clinical data that supported the hypotheses underlying these trials, an...

  6. The Establishment of the Pfizer-Canine Comparative Oncology and Genomics Consortium Biospecimen Repository

    Directory of Open Access Journals (Sweden)

    Christina Mazcko

    2015-07-01

    Full Text Available The Canine Comparative Oncology and Genomics Consortium (CCOGC was formed in 2004 in an effort to capitalize on the generation of a domestic dog genome sequence assembly [1], which created new opportunities to investigate canine cancers at the molecular level [2]. [...

  7. Moral justification of Phase 1 oncology trials.

    Science.gov (United States)

    Dubov, Alex

    2014-06-01

    This article attempts to answer the following normative questions: Can one consider the design of Phase 1 trials ethically appropriate due to the unfavorable ratio of risks and benefits? What are some ethical safeguards for Phase 1 oncology research? A comparative review of literature contributed to the consolidation of the proposed ethical framework for Phase 1 oncology trials. This framework gives a special attention to issues of therapeutic misconception and vulnerability. The benefits and dangers associated with the enrollment in trials are described as well as the absence of alternatives, treatment-specific optimism, and vagueness in factual presentation during the informed consent process. The notion of therapeutic misconception is contrasted with optimism despite realism that stems from psychological, cultural, and religious factors and not necessarily from the lack of information. Close attention is given to the possible ways in which the inherent uncertainty and resulting cognitive biases may affect the informed consent process and the definition of therapeutic misconception. The article ends with recommendations for an ethical way of enrolling palliative patients in early stages of oncology research, giving special attention to provision of adequate consent, protection of vulnerability, and avoidance of therapeutic misconception.

  8. Results of an Oncology Clinical Trial Nurse Role Delineation Study.

    Science.gov (United States)

    Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

    2017-09-01

    To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

  9. Clinical Trials and the Role of the Oncology Clinical Trials Nurse.

    Science.gov (United States)

    Ness, Elizabeth A; Royce, Cheryl

    2017-03-01

    Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model.

  10. Development of a model web-based system to support a statewide quality consortium in radiation oncology.

    Science.gov (United States)

    Moran, Jean M; Feng, Mary; Benedetti, Lisa A; Marsh, Robin; Griffith, Kent A; Matuszak, Martha M; Hess, Michael; McMullen, Matthew; Fisher, Jennifer H; Nurushev, Teamour; Grubb, Margaret; Gardner, Stephen; Nielsen, Daniel; Jagsi, Reshma; Hayman, James A; Pierce, Lori J

    A database in which patient data are compiled allows analytic opportunities for continuous improvements in treatment quality and comparative effectiveness research. We describe the development of a novel, web-based system that supports the collection of complex radiation treatment planning information from centers that use diverse techniques, software, and hardware for radiation oncology care in a statewide quality collaborative, the Michigan Radiation Oncology Quality Consortium (MROQC). The MROQC database seeks to enable assessment of physician- and patient-reported outcomes and quality improvement as a function of treatment planning and delivery techniques for breast and lung cancer patients. We created tools to collect anonymized data based on all plans. The MROQC system representing 24 institutions has been successfully deployed in the state of Michigan. Since 2012, dose-volume histogram and Digital Imaging and Communications in Medicine-radiation therapy plan data and information on simulation, planning, and delivery techniques have been collected. Audits indicated >90% accurate data submission and spurred refinements to data collection methodology. This model web-based system captures detailed, high-quality radiation therapy dosimetry data along with patient- and physician-reported outcomes and clinical data for a radiation therapy collaborative quality initiative. The collaborative nature of the project has been integral to its success. Our methodology can be applied to setting up analogous consortiums and databases. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

  11. Dispositional Optimism and Therapeutic Expectations in Early Phase Oncology Trials

    Science.gov (United States)

    Jansen, Lynn A.; Mahadevan, Daruka; Appelbaum, Paul S.; Klein, William MP; Weinstein, Neil D.; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P.

    2016-01-01

    Purpose Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early phase oncology trials. Optimism, however, is not a unitary construct – it can also be defined as a general disposition, or what is called dispositional optimism. We assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. We also assessed how dispositional optimism related to unrealistic optimism. Methods Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Results Dispositional optimism was significantly associated with higher expectations for personal therapeutic benefit (Spearman r=0.333, poptimism was weakly associated with unrealistic optimism (Spearman r=0.215, p=0.005). In multivariate analysis, both dispositional optimism (p=0.02) and unrealistic optimism (poptimism (p=.0001), but not dispositional optimism, was independently associated with the therapeutic misconception. Conclusion High expectations for therapeutic benefit among patient-subjects in early phase oncology trials should not be assumed to result from misunderstanding of specific information about the trials. Our data reveal that these expectations are associated with either a dispositionally positive outlook on life or biased expectations about specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early phase oncology research. PMID:26882017

  12. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    Thomas eFitzGerald, MD

    2013-03-01

    Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

  13. About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

    Science.gov (United States)

    The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting. |

  14. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

    Science.gov (United States)

    Rodon, J; Soria, J C; Berger, R; Batist, G; Tsimberidou, A; Bresson, C; Lee, J J; Rubin, E; Onn, A; Schilsky, R L; Miller, W H; Eggermont, A M; Mendelsohn, J; Lazar, V; Kurzrock, R

    2015-08-01

    Advances in 'omics' technology and targeted therapeutic molecules are together driving the incorporation of molecular-based diagnostics into the care of patients with cancer. There is an urgent need to assess the efficacy of therapy determined by molecular matching of patients with particular targeted therapies. WINTHER is a clinical trial that uses cutting edge genomic and transcriptomic assays to guide treatment decisions. Through the lens of this ambitious multinational trial (five countries, six sites) coordinated by the Worldwide Innovative Networking Consortium for personalized cancer therapy, we discovered key challenges in initiation and conduct of a prospective, omically driven study. To date, the time from study concept to activation has varied between 19 months at Gustave Roussy Cancer Campus in France to 30 months at the Segal Cancer Center, McGill University (Canada). It took 3+ years to be able to activate US sites due to national regulatory hurdles. Access to medications proposed by the molecular analysis remains a major challenge, since their availability through active clinical trials is highly variable over time within sites and across the network. Rules regarding the off-label use of drugs, or drugs not yet approved at all in some countries, pose a further challenge, and many biopharmaceutical companies lack a simple internal mechanism to supply the drugs even if they wish to do so. These various obstacles should be addressed to test and then implement precision medicine in cancer. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  16. Clinical research in surgical oncology: an analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Menezes, Amber S; Barnes, Alison; Scheer, Adena S; Martel, Guillaume; Moloo, Husein; Boushey, Robin P; Sabri, Elham; Auer, Rebecca C

    2013-11-01

    The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov. Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%). The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.

  17. Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

    Science.gov (United States)

    Ivanova, Anastasia; Paul, Barry; Marchenko, Olga; Song, Guochen; Patel, Neerali; Moschos, Stergios J

    2016-01-01

    We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.

  18. Phase 0 clinical trials in oncology new drug development.

    Science.gov (United States)

    Gupta, Umesh Chandra; Bhatia, Sandeep; Garg, Amit; Sharma, Amit; Choudhary, Vaibhav

    2011-01-01

    Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.

  19. Phase 0 clinical trials in oncology new drug development

    Directory of Open Access Journals (Sweden)

    Umesh Chandra Gupta

    2011-01-01

    Full Text Available Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.

  20. Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?

    Science.gov (United States)

    Malan, Tina; Moodley, Keymanthri

    2016-02-01

    Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word "hope" was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research.

  1. Brain Tumor Epidemiology - A Hub within Multidisciplinary Neuro-oncology. Report on the 15th Brain Tumor Epidemiology Consortium (BTEC) Annual Meeting, Vienna, 2014.

    Science.gov (United States)

    Woehrer, Adelheid; Lau, Ching C; Prayer, Daniela; Bauchet, Luc; Rosenfeld, Myrna; Capper, David; Fisher, Paul G; Kool, Marcel; Müller, Martin; Kros, Johan M; Kruchko, Carol; Wiemels, Joseph; Wrensch, Margaret; Danysh, Heather E; Zouaoui, Sonia; Heck, Julia E; Johnson, Kimberly J; Qi, Xiaoyang; O'Neill, Brian P; Afzal, Samina; Scheurer, Michael E; Bainbridge, Matthew N; Nousome, Darryl; Bahassi, El Mustapha; Hainfellner, Johannes A; Barnholtz-Sloan, Jill S

    2015-01-01

    The Brain Tumor Epidemiology Consortium (BTEC) is an open scientific forum, which fosters the development of multi-center, international and inter-disciplinary collaborations. BTEC aims to develop a better understanding of the etiology, outcomes, and prevention of brain tumors (http://epi.grants.cancer.gov/btec/). The 15th annual Brain Tumor Epidemiology Consortium Meeting, hosted by the Austrian Societies of Neuropathology and Neuro-oncology, was held on September 9 - 11, 2014 in Vienna, Austria. The meeting focused on the central role of brain tumor epidemiology within multidisciplinary neuro-oncology. Knowledge of disease incidence, outcomes, as well as risk factors is fundamental to all fields involved in research and treatment of patients with brain tumors; thus, epidemiology constitutes an important link between disciplines, indeed the very hub. This was reflected by the scientific program, which included various sessions linking brain tumor epidemiology with clinical neuro-oncology, tissue-based research, and cancer registration. Renowned experts from Europe and the United States contributed their personal perspectives stimulating further group discussions. Several concrete action plans evolved for the group to move forward until next year's meeting, which will be held at the Mayo Clinic at Rochester, MN, USA.

  2. Brain Tumor Epidemiology – A Hub within Multidisciplinary Neuro-oncology. Report on the 15th Brain Tumor Epidemiology Consortium (BTEC) Annual Meeting, Vienna, 2014

    Science.gov (United States)

    Woehrer, Adelheid; Lau, Ching C.; Prayer, Daniela; Bauchet, Luc; Rosenfeld, Myrna; Capper, David; Fisher, Paul G.; Kool, Marcel; Müller, Martin; Kros, Johan M.; Kruchko, Carol; Wiemels, Joseph; Wrensch, Margaret; Danysh, Heather E.; Zouaoui, Sonia; Heck, Julia E.; Johnson, Kimberly J.; Qi, Xiaoyang; O’Neill, Brian P.; Afzal, Samina; Scheurer, Michael E.; Bainbridge, Matthew N.; Nousome, Darryl; El Bahassi, Mustapha; Hainfellner, Johannes A.; Barnholtz-Sloan, Jill S.

    2015-01-01

    The Brain Tumor Epidemiology Consortium (BTEC) is an open scientific forum, which fosters the development of multi-center, international and inter-disciplinary collaborations. BTEC aims to develop a better understanding of the etiology, outcomes, and prevention of brain tumors (http://epi.grants.cancer.gov/btec/). The 15th annual Brain Tumor Epidemiology Consortium Meeting, hosted by the Austrian Societies of Neuropathology and Neuro-oncology, was held on September 9 – 11, 2014 in Vienna, Austria. The meeting focused on the central role of brain tumor epidemiology within multidisciplinary neuro-oncology. Knowledge of disease incidence, outcomes, as well as risk factors is fundamental to all fields involved in research and treatment of patients with brain tumors; thus, epidemiology constitutes an important link between disciplines, indeed the very hub. This was reflected by the scientific program, which included various sessions linking brain tumor epidemiology with clinical neuro-oncology, tissue-based research, and cancer registration. Renowned experts from Europe and the United States contributed their personal perspectives stimulating further group discussions. Several concrete action plans evolved for the group to move forward until next year’s meeting, which will be held at the Mayo Clinic at Rochester, MN, USA. PMID:25518914

  3. Innovations for phase I dose-finding designs in pediatric oncology clinical trials.

    Science.gov (United States)

    Doussau, Adelaide; Geoerger, Birgit; Jiménez, Irene; Paoletti, Xavier

    2016-03-01

    Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials. In pediatric oncology, the conduct of those trials raises specific challenges, as the disease is rare with limited therapeutic options. In addition, the tolerance profile is known from adult trials. This paper provides a review of the major recent developments in the design of these trials, inspired by the need to cope with the specific challenges of dose finding in cancer pediatric oncology. We reviewed simulation studies comparing designs dedicated to address these challenges. We also reviewed the design used in published dose-finding trials in pediatric oncology over the period 2009-2014. Three main fields of innovation were identified. First, designs that were developed in order to relax the rules for more flexible inclusions. Second, methods to incorporate data emerging from adult studies. Third, designs accounting for toxicity evaluation at repeated cycles in pediatric oncology. In addition to this overview, we propose some further directions for designing pediatric dose-finding trials.

  4. Clinical trial or standard treatment? Shared decision making at the department of oncology

    DEFF Research Database (Denmark)

    Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

    2016-01-01

    Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

  5. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    Science.gov (United States)

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

    2017-01-01

    Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

  6. Accrual in supportive care trials in pediatric oncology, a challenge!

    NARCIS (Netherlands)

    Schoot, R. A.; van Ommen, C. H.; Caron, H. N.; Tissing, W. J. E.; van de Wetering, M. D.

    2012-01-01

    Treatment protocols in pediatric oncology have historically known high accrual rates, up to 94 %. Accrual for supportive care studies on the other hand appears to be a challenge. The aim of this study was to search for reasons explaining this poor accrual and for possible interventions to improve pa

  7. Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

    Science.gov (United States)

    Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

    2015-01-01

    In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

  8. Immunodynamics: a cancer immunotherapy trials network review of immune monitoring in immuno-oncology clinical trials.

    Science.gov (United States)

    Kohrt, Holbrook E; Tumeh, Paul C; Benson, Don; Bhardwaj, Nina; Brody, Joshua; Formenti, Silvia; Fox, Bernard A; Galon, Jerome; June, Carl H; Kalos, Michael; Kirsch, Ilan; Kleen, Thomas; Kroemer, Guido; Lanier, Lewis; Levy, Ron; Lyerly, H Kim; Maecker, Holden; Marabelle, Aurelien; Melenhorst, Jos; Miller, Jeffrey; Melero, Ignacio; Odunsi, Kunle; Palucka, Karolina; Peoples, George; Ribas, Antoni; Robins, Harlan; Robinson, William; Serafini, Tito; Sondel, Paul; Vivier, Eric; Weber, Jeff; Wolchok, Jedd; Zitvogel, Laurence; Disis, Mary L; Cheever, Martin A

    2016-01-01

    The efficacy of PD-1/PD-L1 targeted therapies in addition to anti-CTLA-4 solidifies immunotherapy as a modality to add to the anticancer arsenal. Despite raising the bar of clinical efficacy, immunologically targeted agents raise new challenges to conventional drug development paradigms by highlighting the limited relevance of assessing standard pharmacokinetics (PK) and pharmacodynamics (PD). Specifically, systemic and intratumoral immune effects have not consistently correlated with standard relationships between systemic dose, toxicity, and efficacy for cytotoxic therapies. Hence, PK and PD paradigms remain inadequate to guide the selection of doses and schedules, both starting and recommended Phase 2 for immunotherapies. The promise of harnessing the immune response against cancer must also be considered in light of unique and potentially serious toxicities. Refining immune endpoints to better inform clinical trial design represents a high priority challenge. The Cancer Immunotherapy Trials Network investigators review the immunodynamic effects of specific classes of immunotherapeutic agents to focus immune assessment modalities and sites, both systemic and importantly intratumoral, which are critical to the success of the rapidly growing field of immuno-oncology.

  9. Approval procedures for clinical trials in the field of radiation oncology; Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie

    Energy Technology Data Exchange (ETDEWEB)

    Simon, Monique; Buettner, Daniel [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Habeck, Matthias; Habeck, Uta; Brix, Gunnar [Bundesamt fuer Strahlenschutz (BfS), Fachbereich Strahlenschutz und Gesundheit, Neuherberg (Germany); Krause, Mechthild; Baumann, Michael [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Helmholtz-Zentrum Dresden - Rossendorf, Institut fuer Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Willich, Normann [Universitaetsklinikum Muenster, Klinik fuer Strahlentherapie - Radioonkologie, Muenster (Germany); Wenz, Frederik [Universitaetsmedizin Mannheim, Medizinische Fakultaet Mannheim, Universitaet Heidelberg, Klinik fuer Strahlentherapie und Radioonkologie, Mannheim (Germany); Schmidberger, Heinz [Universitaetsmedizin Mainz, Klinik fuer Radioonkologie und Strahlentherapie, Mainz (Germany); Debus, Juergen [Universitaetsklinikum Heidelberg, Klinik fuer Radioonkologie und Strahlentherapie, Heidelberg (Germany); Noelling, Torsten

    2015-12-15

    Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt fuer Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for ''medical care (Heilkunde)'' versus ''medical research'' frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. Differentiating between ''Heilkunde'' which does not need to be approved by the BfS and ''medical research'' is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) (''fachkundiger Arzt'' according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial

  10. Novel dose-finding designs and considerations on practical implementations in oncology clinical trials.

    Science.gov (United States)

    Huang, Bo; Bycott, Paul; Talukder, Enayet

    2017-01-01

    One of the main objectives in phase I oncology trials is to evaluate safety and tolerability of an experimental treatment by estimating the maximum tolerated dose (MTD) based on the rate of dose-limiting toxicities (DLT). To meet emerging challenges in dose-finding studies, over the past two decades, extensive research has been conducted by statistical and medical researchers to create innovative dose finding designs that perform better than the standard 3 + 3 design, which often exhibits undesirable statistical and operational properties. However, clinical implementation and practical usage of these new designs have been limited. This article begins with a review of the most recent literature and then provides some perspectives on implementing novel adaptive dose finding designs in oncology phase I trials from a pharmaceutical industry perspective. Statistical planning and logistical considerations on how to effectively execute such designs in multi-center clinical trials are discussed using two recent case studies.

  11. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group.

    Science.gov (United States)

    Galanis, Evanthia; Wu, Wenting; Cloughesy, Timothy; Lamborn, Kathleen; Mann, Bhupinder; Wen, Patrick Y; Reardon, David A; Wick, Wolfgang; Macdonald, David; Armstrong, Terri S; Weller, Michael; Vogelbaum, Michael; Colman, Howard; Sargent, Daniel J; van den Bent, Martin J; Gilbert, Mark; Chang, Susan

    2012-05-01

    Advances in the management of gliomas, including the approval of agents such as temozolomide and bevacizumab, have created an evolving therapeutic landscape in glioma treatment, thus affecting our ability to reliably use historical controls to comparatively assess the activity of new therapies. Furthermore, the increasing availability of novel, targeted agents--which are competing for a small patient population, in view of the low incidence of primary brain tumours--draws attention to the need to improve the efficiency of phase 2 clinical testing in neuro-oncology to expeditiously transition the most promising of these drugs or combinations to potentially practice-changing phase 3 trials. In this report from the Response Assessment in Neurooncology (RANO) group, we review phase 2 trial designs that can address these challenges and capitalise on scientific and clinical advances in brain tumour treatment in neuro-oncology to accelerate and optimise the selection of drugs deserving further testing in phase 3 trials. Although there is still a small role for single-arm and non-comparative phase 2 designs, emphasis is placed on the potential role that comparative randomised phase 2 designs--such as screening designs, selection designs, discontinuation designs, and adaptive designs, including seamless phase 2/3 designs--can have. The rational incorporation of these designs, as determined by the specific clinical setting and the trial's endpoints or goals, has the potential to substantially advance new drug development in neuro-oncology.

  12. Control group design, contamination and drop-out in exercise oncology trials: a systematic review.

    Science.gov (United States)

    Steins Bisschop, Charlotte N; Courneya, Kerry S; Velthuis, Miranda J; Monninkhof, Evelyn M; Jones, Lee W; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H M; May, Anne M

    2015-01-01

    Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-oncology trials and explores the association with contamination and drop-out rates. Randomized controlled exercise-oncology trials from two Cochrane reviews were included. Additionally, a computer-aided search using Medline (Pubmed), Embase and CINAHL was conducted after completion date of the Cochrane reviews. Eligible studies were classified according to three control group design characteristics: the exercise instruction given to controls before start of the study (exercise allowed or not); and the intervention the control group was offered during (any (e.g., education sessions or telephone contacts) or none) or after (any (e.g., cross-over or exercise instruction) or none) the intervention period. Contamination (yes or no) and excess drop-out rates (i.e., drop-out rate of the control group minus the drop-out rate exercise group) were described according to the three design characteristics of the control group and according to the combinations of these three characteristics; so we additionally made subgroups based on combinations of type and timing of instructions received. 40 exercise-oncology trials were included based on pre-specified eligibility criteria. The lowest contamination (7.1% of studies) and low drop-out rates (excess drop-out rate -4.7±9.2) were found in control groups offered an intervention after the intervention period. When control groups were offered an intervention both during and after the intervention period, contamination (0%) and excess drop-out rates (-10.0±12.8%) were even lower. Control groups receiving an intervention during and after the study intervention period have lower contamination and drop-out rates. The present findings can be

  13. The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database.

    Science.gov (United States)

    Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2017-01-01

    In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials.

  14. Dispositional optimism and therapeutic expectations in early-phase oncology trials.

    Science.gov (United States)

    Jansen, Lynn A; Mahadevan, Daruka; Appelbaum, Paul S; Klein, William M P; Weinstein, Neil D; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P

    2016-04-15

    Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism. Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; Poptimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (Poptimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception. High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research. © 2016 American Cancer Society.

  15. Evolution of the randomized controlled trial in oncology over three decades.

    Science.gov (United States)

    Booth, Christopher M; Cescon, David W; Wang, Lisa; Tannock, Ian F; Krzyzanowska, Monika K

    2008-11-20

    The randomized controlled trial (RCT) is the gold standard for establishing new therapies in clinical oncology. Here we document changes with time in design, sponsorship, and outcomes of oncology RCTs. Reports of RCTs evaluating systemic therapy for breast, colorectal (CRC), and non-small-cell lung cancer (NSCLC) published 1975 to 2004 in six major journals were reviewed. Two authors abstracted data regarding trial design, results, and conclusions. Conclusions of authors were graded using a 7-point Likert scale. For each study the effect size for the primary end point was converted to a summary measure. A total of 321 eligible RCTs were included (48% breast, 24% CRC, 28% NSCLC). Over time, the number and size of RCTs increased considerably. For-profit/mixed sponsorship increased substantially during the study period (4% to 57%; P event measures (39% to 78%) and decreasing use of response rate (54% to 14%) as primary end point (P sponsorship were each independently associated with endorsement of the experimental agent (odds ratio [OR] = 19.6, 95% CI, 8.9 to 43.1, and OR = 3.5, 95% CI, 1.6 to 7.5, respectively). RCTs in oncology have become larger and are more likely to be sponsored by industry. Authors of modern RCTs are more likely to strongly endorse novel therapies. For-profit sponsorship and statistically significant results are independently associated with endorsement of the experimental arm.

  16. A novel design for randomized immuno-oncology clinical trials with potentially delayed treatment effects

    Directory of Open Access Journals (Sweden)

    Pei He

    2015-10-01

    Full Text Available The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect. Immuno-oncology therapies pose unique challenges to the design of a trial as the treatment effect may be delayed, which violates the proportional hazards assumption, and the log-rank test has been shown to markedly lose power under the non-proportional hazards setting. A novel design and analysis approach for immuno-oncology trials is proposed through a piecewise treatment effect function, which is capable of detecting a potentially delayed treatment effect. The number of events required for the trial will be determined to ensure sufficient power for both the overall log-rank test without a delayed effect and the test beyond the delayed period when such a delay exists. The existence of a treatment delay is determined by a likelihood ratio test with resampling. Numerical results show that the proposed design adequately controls the Type I error rate, has a minimal loss in power under the proportional hazards setting and is markedly more powerful than the log-rank test with a delayed treatment effect.

  17. Robotic Surgery in Uro-Oncology: a Systematic Review and Meta-Analysis of Randomised Controlled Trials.

    Science.gov (United States)

    Steffens, Daniel; Thanigasalam, Ruban; Leslie, Scott; Maneck, Bharvi; Young, Jane M; Solomon, Michael

    2017-03-20

    Robotic surgery represents a new horizon in minimally-invasive urological surgery. This systematic review of the literature and meta-analysis examines the effectiveness of robotic surgery compared with laparoscopic or open surgery for major uro-oncological procedures. 25 articles reported findings from 8 trials of prostatectomy (4 trials) and cystectomy (4 trials) including 1033 participants. Robotic surgery is comparable to laparoscopic or open surgery for oncological outcomes, overall complications, and provides somewhat better functional outcome, when compared to laparoscopic and open surgery.

  18. Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

    Science.gov (United States)

    Hurd, Thelma C; Kaplan, Charles D; Cook, Elise D; Chilton, Janice A; Lytton, Jay S; Hawk, Ernest T; Jones, Lovell A

    2017-04-01

    Trust is the cornerstone of clinical trial recruitment and retention. Efforts to decrease barriers and increase clinical trial participation among diverse populations have yielded modest results. There is an urgent need to better understand the complex interactions between trust and clinical trial participation. The process of trust-building has been a focus of intense research in the business community. Yet, little has been published about trust in oncology clinical trials or the process of building trust in clinical trials. Both clinical trials and business share common dimensions. Business strategies for building trust may be transferable to the clinical trial setting. This study was conducted to understand and utilize contemporary thinking about building trust to develop an Integrated Model of Trust that incorporates both clinical and business perspectives. A key word-directed literature search of the PubMed, Medline, Cochrane, and Google Search databases for entries dated between 1 January 1985 and 1 September 2015 was conducted to obtain information from which to develop an Integrated Model of Trust. Successful trial participation requires both participants and clinical trial team members to build distinctly different types of interpersonal trust to effect recruitment and retention. They are built under conditions of significant emotional stress and time constraints among people who do not know each other and have never worked together before. Swift Trust and Traditional Trust are sequentially built during the clinical trial process. Swift trust operates during the recruitment and very early active treatment phases of the clinical trial process. Traditional trust is built over time and operates during the active treatment and surveillance stages of clinical trials. The Psychological Contract frames the participants' and clinical trial team members' interpersonal trust relationship. The "terms" of interpersonal trust are negotiated through the psychological

  19. Drug induced interstitial lung disease in oncology phase I trials.

    Science.gov (United States)

    Yonemori, Kan; Hirakawa, Akihiro; Kawachi, Asuka; Kinoshita, Fumie; Okuma, Hitomi; Nishikawa, Tadaaki; Tamura, Kenji; Fujiwara, Yasuhiro; Takebe, Naoko

    2016-12-01

    Interstitial lung disease is a serious drug-related condition that can cause life threatening organ failure. The incidence and risk factors of drug-induced interstitial lung disease (DILD) are unknown in oncology phase I trials. This study analyzed clinical information from 8906 patients with malignancies who were enrolled in 470 phase I trials sponsored by the Cancer Therapy Evaluation Program, National Cancer Institute, from 1988 to 2014. Logistic and Cox statistical analyses were utilized to determine clinical differences between patients who developed DILD and patients who did not. In this study, the overall incidence rate of patients with pulmonary toxicity was 2.7%. The overall incidence rate for DILD was 0.77%, whereas for grade 3 or 4 DILD it was 0.31%. Median time to occurrence of DILD was 1.4 months. The Cox hazard analysis indicated smaller body surface area and a combination of thoracic radiation with investigational drug regimens were significant risk factors for time to occurrence of interstitial lung disease. Investigators should carefully monitor for DILD in oncology patients enrolled in phase I trials with identified risk factors. A 6-month observation period would be sufficient to detect the onset of most DILD in such patients.

  20. Designs and challenges for personalized medicine studies in oncology: focus on the SHIVA trial.

    Science.gov (United States)

    Le Tourneau, Christophe; Kamal, Maud; Trédan, Olivier; Delord, Jean-Pierre; Campone, Mario; Goncalves, Anthony; Isambert, Nicolas; Conroy, Thierry; Gentien, David; Vincent-Salomon, Anne; Pouliquen, Anne-Lise; Servant, Nicolas; Stern, Marc-Henri; Le Corroller, Anne-Gaëlle; Armanet, Sébastien; Rio Frio, Thomas; Paoletti, Xavier

    2012-12-01

    Personalized medicine is defined by the National Cancer Institute as "a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, and treat disease." In oncology, the term "personalized medicine" arose with the emergence of molecularly targeted agents. The prescription of approved molecularly targeted agents to cancer patients currently relies on the primary tumor location and histological subtype. Predictive biomarkers of efficacy of these modern agents have been exclusively validated in specific tumor types. A major concern today is to determine whether the prescription of molecularly targeted therapies based on tumor molecular abnormalities, independently of primary tumor location and histology, would improve the outcome of cancer patients. This new paradigm requires prospective validation before being implemented in clinical practice. In this paper, we will first review different designs, including observational cohorts, as well as nonrandomized and randomized clinical trials, that have been recently proposed to evaluate the relevance of this approach, and further discuss their advantages and drawbacks. The design of the SHIVA trial, a randomized proof-of-concept phase II trial comparing therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer will be detailed. Finally, we will discuss the multiple challenges associated with the implementation of personalized medicine in oncology, as well as perspectives for the future.

  1. Randomized controlled trials and neuro-oncology: should alternative designs be considered?

    Science.gov (United States)

    Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

    2015-09-01

    Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

  2. A quality control program within a clinical trial Consortium for PCR protocols to detect Plasmodium species.

    Science.gov (United States)

    Taylor, Steve M; Mayor, Alfredo; Mombo-Ngoma, Ghyslain; Kenguele, Hilaire M; Ouédraogo, Smaïla; Ndam, Nicaise Tuikue; Mkali, Happy; Mwangoka, Grace; Valecha, Neena; Singh, Jai Prakash Narayan; Clark, Martha A; Verweij, Jaco J; Adegnika, Ayola Akim; Severini, Carlo; Menegon, Michela; Macete, Eusebio; Menendez, Clara; Cisteró, Pau; Njie, Fanta; Affara, Muna; Otieno, Kephas; Kariuki, Simon; ter Kuile, Feiko O; Meshnick, Steven R

    2014-06-01

    Malaria parasite infections that are only detectable by molecular methods are highly prevalent and represent a potential transmission reservoir. The methods used to detect these infections are not standardized, and their operating characteristics are often unknown. We designed a proficiency panel of Plasmodium spp. in order to compare the accuracy of parasite detection of molecular protocols used by labs in a clinical trial consortium. Ten dried blood spots (DBSs) were assembled that contained P. falciparum, P. vivax, P. malariae, and P. ovale; DBSs contained either a single species or a species mixed with P. falciparum. DBS panels were tested in 9 participating laboratories in a masked fashion. Of 90 tests, 68 (75.6%) were correct; there were 20 false-negative results and 2 false positives. The detection rate was 77.8% (49/63) for P. falciparum, 91.7% (11/12) for P. vivax, 83.3% (10/12) for P. malariae, and 70% (7/10) for P. ovale. Most false-negative P. falciparum results were from samples with an estimated ≤ 5 parasites per μl of blood. Between labs, accuracy ranged from 100% to 50%. In one lab, the inability to detect species in mixed-species infections prompted a redesign and improvement of the assay. Most PCR-based protocols were able to detect P. falciparum and P. vivax at higher densities, but these assays may not reliably detect parasites in samples with low P. falciparum densities. Accordingly, formal quality assurance for PCR should be employed whenever this method is used for diagnosis or surveillance. Such efforts will be important if PCR is to be widely employed to assist malaria elimination efforts.

  3. Field trial on removal of petroleum-hydrocarbon pollutants using a microbial consortium for bioremediation and rhizoremediation.

    Science.gov (United States)

    Pizarro-Tobías, Paloma; Niqui, José L; Roca, Amalia; Solano, Jennifer; Fernández, Matilde; Bastida, Felipe; García, Carlos; Ramos, Juan L

    2015-02-01

    Petroleum waste sludges are toxic and dangerous that is why environmental protection agencies have declared their treatment top priority. Physicochemical treatments are expensive and environmentally unfriendly, while alternative biological treatments are less costly but, in general, work at a slower pace. An in situ bioremediation and rhizoremediation field scale trial was performed in an area contaminated with oil refinery sludge under semiarid climate. The bioremediation and rhizoremediation treatments included the use of an artificial consortium made up of plant growth-promoting rhizobacteria and polycyclic aromatic hydrocarbon-degrading bacteria,and the combined use of the mentioned consortium along with pasture plants respectively. Rhizoremediation revealed that the development of vegetation favoured the evolution of indigenous microbiota with potential to remove petroleum wastes. This was inferred as the decline of total petroleum hydrocarbons 7 months after the biological treatment.

  4. Physician recruitment of patients to non-therapeutic oncology clinical trials: ethics revisited

    Directory of Open Access Journals (Sweden)

    Lee eBlack

    2013-03-01

    Full Text Available Tailoring medical treatment to individual patients requires a strong foundation in research to provide the data necessary to understand the relationship between the disease, the patient, and the type of treatment advocated for. Non-therapeutic oncology clinical trials studying therapeutic resistance require the participation of patients, yet only a small percentage enroll. Treating physicians are often relied on to recruit patients, but they have a number of ethical obligations that might be perceived as barriers to recruiting. Concepts such as voluntariness of consent and conflicts of interest can have an impact on whether physicians will discuss clinical trials with their patients and how patients perceive the information. However, these ethical obligations should not be prohibitive to physician recruitment of patients—precautions can be taken to ensure that patients’ consent to research participation is fully voluntary and devoid of conflict, such as the use of other members of the research team than the treating physician to discuss the trial and obtain consent, and better communication between researchers, clinicians and patients. These can ensure that research benefits are maximized for the good of patients and society.

  5. Surgical trials in oncology. the importance of quality control in the TME trial.

    Science.gov (United States)

    Klein Kranenbarg, E; van de Velde, C J H

    2002-05-01

    Results from randomised trials provide the best scientific evidence of efficacy or inefficacy of the therapy. The evaluation of surgical procedures involves problems in addition to those associated with medical experimentation. Surgery, unlike a pill, is not a standardised, reproducible entity, but a unique product whose details are defined by, for example, the skill of the surgeon. Quality assurance is important for treatment and also for data handling. The different treatments (surgery, pathology, radiotherapy, etc.) should be familiar to all participating physicians prior to the start of the trial. Instructions can be given by means of a well-written protocol, videotapes, workshops and instructors at the dissection table. The data collection and data check should be done by data managers and co-ordinators for the separate disciplines. Errors and missing data should be completed and feedback to the physician is essential. Close contact between an active co-ordinating data centre, including co-ordinators for the separate disciplines, and all participating physicians is essential to conduct a quality controlled multicentre, multidisciplinary trial. Continuous enthusiasm can be maintained by the organisation of regular workshops, distribution of newsletters and trial up-dates at scientific meetings. The efforts from all of the involved co-ordinators, data managers, instructors and physicians have resulted in a very successful trial with rapid accrual, good quality treatments and procedures, good quality data, and a high participation rate among hospitals and patients. Quality control is expensive and labour-intensive, but it is worthwhile.

  6. Bioinformatics for precision medicine in oncology: principles and application to the SHIVA clinical trial.

    Science.gov (United States)

    Servant, Nicolas; Roméjon, Julien; Gestraud, Pierre; La Rosa, Philippe; Lucotte, Georges; Lair, Séverine; Bernard, Virginie; Zeitouni, Bruno; Coffin, Fanny; Jules-Clément, Gérôme; Yvon, Florent; Lermine, Alban; Poullet, Patrick; Liva, Stéphane; Pook, Stuart; Popova, Tatiana; Barette, Camille; Prud'homme, François; Dick, Jean-Gabriel; Kamal, Maud; Le Tourneau, Christophe; Barillot, Emmanuel; Hupé, Philippe

    2014-01-01

    Precision medicine (PM) requires the delivery of individually adapted medical care based on the genetic characteristics of each patient and his/her tumor. The last decade witnessed the development of high-throughput technologies such as microarrays and next-generation sequencing which paved the way to PM in the field of oncology. While the cost of these technologies decreases, we are facing an exponential increase in the amount of data produced. Our ability to use this information in daily practice relies strongly on the availability of an efficient bioinformatics system that assists in the translation of knowledge from the bench towards molecular targeting and diagnosis. Clinical trials and routine diagnoses constitute different approaches, both requiring a strong bioinformatics environment capable of (i) warranting the integration and the traceability of data, (ii) ensuring the correct processing and analyses of genomic data, and (iii) applying well-defined and reproducible procedures for workflow management and decision-making. To address the issues, a seamless information system was developed at Institut Curie which facilitates the data integration and tracks in real-time the processing of individual samples. Moreover, computational pipelines were developed to identify reliably genomic alterations and mutations from the molecular profiles of each patient. After a rigorous quality control, a meaningful report is delivered to the clinicians and biologists for the therapeutic decision. The complete bioinformatics environment and the key points of its implementation are presented in the context of the SHIVA clinical trial, a multicentric randomized phase II trial comparing targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer. The numerous challenges faced in practice during the setting up and the conduct of this trial are discussed as an illustration of PM application.

  7. Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement.

    Science.gov (United States)

    Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn; Ballard, Rachel M; Bruinooge, Suanna S; Courneya, Kerry S; Daniels, Elvan C; Demark-Wahnefried, Wendy; Frank, Elizabeth S; Goodwin, Pamela J; Irwin, Melinda L; Levit, Laura A; McCaskill-Stevens, Worta; Minasian, Lori M; O'Rourke, Mark A; Pierce, John P; Stein, Kevin D; Thomson, Cynthia A; Hudis, Clifford A

    2015-11-20

    Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a routine part of cancer care. The ASCO Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice. Recommendations highlight the need for large-scale trials evaluating the impact of energy balance interventions on cancer outcomes, as well as the concurrent conduct of studies focused on dissemination and implementation of interventions in diverse populations of cancer survivors, including answering critical questions about the degree of benefit in key subgroups of survivors. Other considerations include the importance of incorporating economic metrics into energy balance intervention trials, the need to establish intermediate biomarkers, and the importance of integrating traditional and nontraditional funding sources. Establishing lifestyle change after cancer diagnosis as a routine part of cancer care will require a multipronged effort to overcome barriers related to study development, funding, and stakeholder engagement. Given the prevalence of obesity and inactivity in cancer survivors in the United States and elsewhere, energy balance interventions hold the potential to reduce cancer morbidity and mortality in millions of patients, and it is essential that we move forward in determining their role in cancer care with the same care and

  8. Bioinformatics for Precision Medicine in Oncology: principles and application to the SHIVA clinical trial

    Directory of Open Access Journals (Sweden)

    Nicolas eServant

    2014-05-01

    Full Text Available Precision medicine (PM requires the delivery of individually adapted medical care based on the genetic characteristics of each patient and his/her tumor. The last decade witnessed the development of high-throughput technologies such as microarrays and next-generation sequencing which paved the way to PM in the field of oncology. While the cost of these technologies decreases, we are facing an exponential increase in the amount of data produced. Our ability to use this information in daily practice relies strongly on the availability of an efficient bioinformatics system that assists in the translation of knowledge from the bench towards molecular targeting and diagnosis. Clinical trials and routine diagnoses constitute different approaches, both requiring a strong bioinformatics environment capable of i warranting the integration and the traceability of data, ii ensuring the correct processing and analyses of genomic data and iii applying well-defined and reproducible procedures for workflow management and decision-making. To address the issues, a seamless information system was developed at Institut Curie which facilitates the data integration and tracks in real-time the processing of individual samples. Moreover, computational pipelines were developed to identify reliably genomic alterations and mutations from the molecular profiles of each patient. After a rigorous quality control, a meaningful report is delivered to the clinicians and biologists for the therapeutic decision. The complete bioinformatics environment and the key points of its implementation are presented in the context of the SHIVA clinical trial, a multicentric randomized phase II trial comparing targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer. The numerous challenges faced in practice during the setting up and the conduct of this trial are discussed as an illustration of PM application.

  9. Methods for adjusting for bias due to crossover in oncology trials.

    Science.gov (United States)

    Ishak, K Jack; Proskorovsky, Irina; Korytowsky, Beata; Sandin, Rickard; Faivre, Sandrine; Valle, Juan

    2014-06-01

    Trials of new oncology treatments often involve a crossover element in their design that allows patients receiving the control treatment to crossover to receive the experimental treatment at disease progression or when sufficient evidence about the efficacy of the new treatment is achieved. Crossover leads to contamination of the initial randomized groups due to a mixing of the effects of the control and experimental treatments in the reference group. This is further complicated by the fact that crossover is often a very selective process whereby patients who switch treatment have a different prognosis than those who do not. Standard statistical techniques, including those that attempt to account for the treatment switch, cannot fully adjust for the bias introduced by crossover. Specialized methods such as rank-preserving structural failure time (RPSFT) models and inverse probability of censoring weighted (IPCW) analyses are designed to deal with selective treatment switching and have been increasingly applied to adjust for crossover. We provide an overview of the crossover problem and highlight circumstances under which it is likely to cause bias. We then describe the RPSFT and IPCW methods and explain how these methods adjust for the bias, highlighting the assumptions invoked in the process. Our aim is to facilitate understanding of these complex methods using a case study to support explanations. We also discuss the implications of crossover adjustment on cost-effectiveness results.

  10. The MRI-Linear Accelerator Consortium: Evidence-Based Clinical Introduction of an Innovation in Radiation Oncology Connecting Researchers, Methodology, Data Collection, Quality Assurance, and Technical Development

    Science.gov (United States)

    Kerkmeijer, Linda G. W.; Fuller, Clifton D.; Verkooijen, Helena M.; Verheij, Marcel; Choudhury, Ananya; Harrington, Kevin J.; Schultz, Chris; Sahgal, Arjun; Frank, Steven J.; Goldwein, Joel; Brown, Kevin J.; Minsky, Bruce D.; van Vulpen, Marco

    2016-01-01

    An international research consortium has been formed to facilitate evidence-based introduction of MR-guided radiotherapy (MR-linac) and to address how the MR-linac could be used to achieve an optimized radiation treatment approach to improve patients’ survival, local, and regional tumor control and quality of life. The present paper describes the organizational structure of the clinical part of the MR-linac consortium. Furthermore, it elucidates why collaboration on this large project is necessary, and how a central data registry program will be implemented. PMID:27790408

  11. Feasibility of the EORTC/NCIC Trial Protocol in a Neurosurgical Outpatient Unit: The Case for Neurosurgical Neuro-Oncology.

    Science.gov (United States)

    Rapp, Marion; Sadat, Hosai; Slotty, Philipp Joerg; Steiger, Hans Jakob; Budach, Wilfried; Sabel, Michael

    2015-07-01

    With the publication of the European Organization for Research and Treatment of Cancer/National Cancer Information Center (EORTC/NCIC) trial, concomitant radiochemotherapy followed by intermittent chemotherapy became the new treatment standard for patients with primary glioblastoma. Eight years after widespread introduction of this protocol, it is of interest to investigate whether this new standard has been established in daily neuro-oncologic practice. We were particularly interested in its practicality within a neurosurgical neuro-oncologic setting. We analyzed primary glioblastoma patients diagnosed between 2005 and 2013 treated at our center according to the EORTC/NCIC trial. Parameters associated with treatment performance (interruption of radiotherapy, concomitant chemotherapy and intermittent chemotherapy, total number of cycles, and side effects) were retrospectively analyzed and compared with the available data from the EORTC/NCIC trial. In this single-center retrospective study, we identified 189 patients (116 men, 73 women; median age: 62 years) who were treated according to the EORTC/NCIC trial protocol. A total of 176 patients received cytoreductive surgery; 13 patients had stereotactic biopsy only (EORTC/NCIC trial: 239 patients and 48 patients, respectively). Radiotherapy had to be interrupted in 9 patients (5%) (EORTC/NCIC trial: 15 patients [5%]) and concomitant chemotherapy in 26 patients (14%) (EORTC/NCIC trial: 37 patients [13%]). In 156 patients (83%), adjuvant TMZ chemotherapy was initiated (6 median temozolomide [TMZ] cycles; range: 1-30). In the EORTC/NCIC trial, 223 patients (47%) received the intermittent chemotherapy protocol (median: 3 cycles; range: 1-7). Overall, 97 patients (62%) completed 6 TMZ cycles (EORTC/NCIC-trial: 105 patients [47%]); dose escalation to 200 mg/qm at the second cycle was performed in 91 patients (58%) (versus 149 patients [67%]). Intermittent TMZ therapy was discontinued in 59 patients (38%) (versus 118

  12. Cultural Competency Training to Increase Minority Enrollment into Radiation Therapy Clinical Trials-an NRG Oncology RTOG Study.

    Science.gov (United States)

    Wells, Jessica S; Pugh, Stephanie; Boparai, Karan; Rearden, Jessica; Yeager, Katherine A; Bruner, Deborah W

    2016-05-21

    Despite initiatives to increase the enrollment of racial and ethnic minorities into cancer clinical trials in the National Cancer Institute National Cancer Clinical Trials Network (NCCTN), participation by Latino and African American populations remain low. The primary aims of this pilot study are (1) to develop a Cultural Competency and Recruitment Training Program (CCRTP) for physician investigators and clinical research associates (CRAs), (2) to determine if the CCRTP increases cultural competency scores among physician investigators and CRAs, and (3) to determine the impact of the CCRTP on minority patient recruitment into NRG Oncology Radiation Therapy Oncology Group (RTOG) clinical trials. Sixty-seven CRAs and physicians participated in an in-person or online 4-h CRRTP training. Five knowledge and attitude items showed significant improvements from pre- to post-training. A comparison between enrolling sites that did and did not participate in the CCRTP demonstrated a pre to 1-year post-incremental increase in minority accrual to clinical trials of 1.2 % among participating sites. While not statistically significant, this increase translated into an additional 300 minority patients accrued to NCCTN clinical trials in the year following the training from those sites who participated in the training.

  13. Liquid dynamic medicine and N-of-1 clinical trials: a change of perspective in oncology research.

    Science.gov (United States)

    Silvestris, Nicola; Ciliberto, Gennaro; De Paoli, Paolo; Apolone, Giovanni; Lavitrano, Maria Luisa; Pierotti, Marco A; Stanta, Giorgio

    2017-09-13

    The increasing use of genomics to define the pattern of actionable mutations and to test and validate new therapies for individual cancer patients, and the growing application of liquid biopsy to dynamically track tumor evolution and to adapt molecularly targeted therapy according to the emergence of tumor clonal variants is shaping modern medical oncology., In order to better describe this new therapeutic paradigm we propose the term "Liquid dynamic medicine" in the place of "Personalized or Precision medicine". Clinical validation of the "Liquid dynamic medicine" approach is best captured by N-of-1 trials where each patient acts as tester and control of truly personalized therapies.

  14. New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs

    Institute of Scientific and Technical Information of China (English)

    Robert A.Beckman; Cong Chen

    2013-01-01

    Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy,increase the value of cancer medicines,and decrease the size and cost of clinical trials while increasing their chance of success.But predictive biomarkers do not always work.When unsuccessful,they add cost,complexity,and time to drug development.This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes.In the end,the biomarker is emphasized to the extent that it can actually predict.

  15. Object-oriented business process analysis of the cooperative soft tissue sarcoma trial of the german society for paediatric oncology and haematology (GPOH).

    Science.gov (United States)

    Weber, R; Knaup, P; Knietitg, R; Haux, R; Merzweiler, A; Mludek, V; Schilling, F H; Wiedemann, T

    2001-01-01

    The German Society for Paediatric Oncology and Haematology (GPOH) runs nation-wide multicentre clinical trials to improve the treatment of children suffering from malignant diseases. We want to provide methods and tools to support the centres of these trials in developing trial specific modules for the computer-based DOcumentation System for Paediatric Oncology (DOSPO). For this we carried out an object-oriented business process analysis for the Cooperative Soft Tissue Sarcoma Trial at the Olgahospital Stuttgart for Child and Adolescent Medicine. The result is a comprehensive business process model consisting of UML-diagrams and use case specifications. We recommend the object-oriented business process analysis as a method for the definition of requirements in information processing projects in the field of clinical trials in general. For this our model can serve as basis because it slightly can be adjusted to each type of clinical trial.

  16. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2016-01-14

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology.

  17. A phase II trial of CPT-11 in recurrent squamous carcinoma of the cervix: a gynecologic oncology group study.

    Science.gov (United States)

    Look, K Y; Blessing, J A; Levenback, C; Kohler, M; Chafe, W; Roman, L D

    1998-09-01

    To determine the response rate and associated toxicity of weekly CPT-11 in squamous carcinoma of the cervix. From October 1994 to May 1996, the Gynecologic Oncology Group (GOG) conducted a Phase II trial in patients with recurrent squamous cervix carcinoma. The schedule employed weekly x4 intravenous CPT-11 at 125 mg/m2 followed with a 2-week rest, to be repeated until disease progression or unacceptable toxicity. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, adequate liver function, and serum creatinine OFFis schedule of CPT-11 exhibits modest activity with moderate toxicity in patients with recurrent squamous carcinoma of the cervix. Copyright 1998 Academic Press.

  18. Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials

    Directory of Open Access Journals (Sweden)

    Goffin John R

    2011-12-01

    Full Text Available Abstract Background Response rate (RR, the most common early means of assessing oncology drugs, is not suitable as the sole endpoint for phase II trials of drugs which induce disease stability but not regression. Time to progression (TTP may be more sensitive to such agents, but induces recruitment delays in multistage studies. Early progressive disease (EPD is the earliest signal of time to progression, but is less intuitive to investigators, To study drugs with unknown anti-tumour effect, we designed the Combination Stopping Rule (CSR, which allows investigators to establish a hypothesis using RR and TTP, while the program also employs early progressive disease (EPD to assess for drug inactivity during the first stage of study accrual. Methods A computer program was created to generate stopping rules based on specified error rates, trial size, and RR and median TTP of interest and disinterest for a two-stage phase II trial. Rules were generated for stage II such that the null hypothesis (Hnul was rejected if either RR or TTP met desired thresholds, and accepted if both did not. Assuming an exponential distribution for progression, EPD thresholds were determined based on specified TTP values. Stopping rules were generated for stage I such that Hnul was accepted and the study stopped if both RR and EPD were unacceptable. Results Patient thresholds were generated for RR, median TTP, and EPD which achieved specified error rates and which allowed early stopping based on RR and EPD. For smaller proportional differences between interesting and disinteresting values of RR or TTP, larger trials are required to maintain alpha error, and early stopping is more common with a larger first stage. Conclusion Stopping rules are provided for phase II trials for drugs which have either a desirable RR or TTP. In addition, early stopping can be achieved using RR and EPD.

  19. Standardizing Naming Conventions in Radiation Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Santanam, Lakshmi [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Hurkmans, Coen [Department of Radiation Oncology, Catharina Hospital, Eindhoven (Netherlands); Mutic, Sasa [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Vliet-Vroegindeweij, Corine van [Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, PA (United States); Brame, Scott; Straube, William [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Galvin, James [Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, PA (United States); Tripuraneni, Prabhakar [Department of Radiation Oncology, Scripps Clinic, LaJolla, CA (United States); Michalski, Jeff [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Bosch, Walter, E-mail: wbosch@radonc.wustl.edu [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, MO (United States); Advanced Technology Consortium, Image-guided Therapy QA Center, St. Louis, MO (United States)

    2012-07-15

    Purpose: The aim of this study was to report on the development of a standardized target and organ-at-risk naming convention for use in radiation therapy and to present the nomenclature for structure naming for interinstitutional data sharing, clinical trial repositories, integrated multi-institutional collaborative databases, and quality control centers. This taxonomy should also enable improved plan benchmarking between clinical institutions and vendors and facilitation of automated treatment plan quality control. Materials and Methods: The Advanced Technology Consortium, Washington University in St. Louis, Radiation Therapy Oncology Group, Dutch Radiation Oncology Society, and the Clinical Trials RT QA Harmonization Group collaborated in creating this new naming convention. The International Commission on Radiation Units and Measurements guidelines have been used to create standardized nomenclature for target volumes (clinical target volume, internal target volume, planning target volume, etc.), organs at risk, and planning organ-at-risk volumes in radiation therapy. The nomenclature also includes rules for specifying laterality and margins for various structures. The naming rules distinguish tumor and nodal planning target volumes, with correspondence to their respective tumor/nodal clinical target volumes. It also provides rules for basic structure naming, as well as an option for more detailed names. Names of nonstandard structures used mainly for plan optimization or evaluation (rings, islands of dose avoidance, islands where additional dose is needed [dose painting]) are identified separately. Results: In addition to its use in 16 ongoing Radiation Therapy Oncology Group advanced technology clinical trial protocols and several new European Organization for Research and Treatment of Cancer protocols, a pilot version of this naming convention has been evaluated using patient data sets with varying treatment sites. All structures in these data sets were

  20. 'The trial is owned by the team, not by an individual': a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology.

    Science.gov (United States)

    Strong, Sean; Paramasivan, Sangeetha; Mills, Nicola; Wilson, Caroline; Donovan, Jenny L; Blazeby, Jane M

    2016-04-26

    Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties. Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently. Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner. This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs. International

  1. Pathology is a necessary and informative tool in oncology clinical trials.

    Science.gov (United States)

    Nagtegaal, Iris D; West, Nicholas P; van Krieken, J Han J M; Quirke, Phil

    2014-01-01

    Clinical trials are essential for the improvement of cancer care. The complexity of modern cancer care and research require careful design, for which input from all disciplines is necessary. Pathologists should play a key role in the design and execution of modern cancer trials, with special attention to the eligibility, stratification and evaluation of response to therapy. In the current review all these aspects are discussed, with examples from colorectal cancer trials. We describe critical issues in biomarker evaluation and development and emphasize the importance of the role of the pathologist in quality control of cancer treatment.

  2. Genomics-based early-phase clinical trials in oncology: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies.

    Science.gov (United States)

    Liu, Stephen V; Miller, Vincent A; Lobbezoo, Marinus W; Giaccone, Giuseppe

    2014-11-01

    The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force discussed incorporation of genomic profiling into early (Phase I and II) clinical trials in oncology. The task force reviewed the challenges of standardising genomics data in a manner conducive to conducting clinical trials. Current barriers to successful and efficient implementation were identified and discussed, as well as the methods of genomic analysis, the proper setting for study and strategies to facilitate timely completion of genomics-based studies. The importance of properly capturing and cataloguing outcomes was also discussed. Several recommendations regarding the use of genomics in these trials are provided.

  3. Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials : A Systematic Review

    NARCIS (Netherlands)

    Bisschop, Charlotte N. Steins; Courneya, Kerry S.; Velthuis, Miranda J.; Monninkhof, Evelyn M.; Jones, Lee W.; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H. M.; May, Anne M.

    2015-01-01

    Purpose Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of

  4. A risk management approach for imaging biomarker-driven clinical trials in oncology.

    Science.gov (United States)

    Liu, Yan; deSouza, Nandita M; Shankar, Lalitha K; Kauczor, Hans-Ulrich; Trattnig, Siegfried; Collette, Sandra; Chiti, Arturo

    2015-12-01

    Imaging has steadily evolved in clinical cancer research as a result of improved conventional imaging methods and the innovation of new functional and molecular imaging techniques. Despite this evolution, the design and data quality derived from imaging within clinical trials are not ideal and gaps exist with paucity of optimised methods, constraints of trial operational support, and scarce resources. Difficulties associated with integrating imaging biomarkers into trials have been neglected compared with inclusion of tissue and blood biomarkers, largely because of inherent challenges in the complexity of imaging technologies, safety issues related to new imaging contrast media, standardisation of image acquisition across multivendor platforms, and various postprocessing options available with advanced software. Ignorance of these pitfalls directly affects the quality of the imaging read-out, leading to trial failure, particularly when imaging is a primary endpoint. Therefore, we propose a practical risk-based framework and recommendations for trials driven by imaging biomarkers, which allow identification of risks at trial initiation to better allocate resources and prioritise key tasks. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Cui Yunfeng [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States); Parker, William [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada); Breen, Stephen [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada); Yin Fangfang; Cai Jing [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States); Papiez, Lech S. [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Li, X. Allen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Bednarz, Greg [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Chen Wenzhou [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Xiao Ying, E-mail: ying.xiao@jefferson.edu [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States)

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA

  6. Implementation of remote 3-dimensional image guided radiation therapy quality assurance for radiation therapy oncology group clinical trials.

    Science.gov (United States)

    Cui, Yunfeng; Galvin, James M; Parker, William; Breen, Stephen; Yin, Fang-Fang; Cai, Jing; Papiez, Lech S; Li, X Allen; Bednarz, Greg; Chen, Wenzhou; Xiao, Ying

    2013-01-01

    To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. This first experience indicated that remote review for 3D IGRT as part of QA for RTOG clinical trials is feasible and effective

  7. Dose Titration Algorithm Tuning (DTAT) should supersede 'the' Maximum Tolerated Dose (MTD) in oncology dose-finding trials.

    Science.gov (United States)

    Norris, David C

    2017-01-01

    Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent 'confirmatory' Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational therapy. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of 'the' maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived, not as 'dose-finding', but as dose titration algorithm (DTA)-finding. Methods. A Phase I dosing study is simulated, for a notional cytotoxic chemotherapy drug, with neutropenia constituting the critical dose-limiting toxicity. The drug's population pharmacokinetics and myelosuppression dynamics are simulated using published parameter estimates for docetaxel. The amenability of this model to linearization is explored empirically. The properties of a simple DTA targeting neutrophil nadir of 500 cells/mm (3) using a Newton-Raphson heuristic are explored through simulation in 25 simulated study subjects. Results. Individual-level myelosuppression dynamics in the simulation model approximately linearize under simple transformations of neutrophil concentration and drug dose. The simulated dose titration exhibits largely satisfactory convergence, with great variance in individualized optimal dosing. Some titration courses exhibit overshooting. Conclusions. The large inter-individual variability in simulated optimal dosing underscores the need to replace 'the' MTD with an individualized concept of MTD i . To illustrate this principle, the simplest possible DTA capable of realizing such a concept is demonstrated. Qualitative phenomena observed in this demonstration support discussion of the notion of tuning such algorithms. Although here illustrated specifically in relation to

  8. The clinical and financial impact of a pediatric surgical neuro-oncology clinical trial.

    Science.gov (United States)

    Thompson, Eric M; Gururangan, Sridharan; Grant, Gerald; Mitchell, Duane; Sampson, John H

    2017-03-01

    Pediatric surgical trials are rare and the impact of such trials on the institutions in which they are conducted is unknown. The purpose of this study was to analyze the clinical and financial impact of The Re-MATCH trial, a Phase I clinical trial requiring the biopsy or resection of recurrent medulloblastoma or PNET for enrollment. Inpatient financial and clinical volume information was collected during the 3 years of trial enrollment and the years preceding and following it. The primary endpoints were the difference in direct contribution margin (DCM), or net gain, of study and non-study patients and the difference in surgical volume during the study and non-study periods. The trial enrolled 18 patients; 15 had surgery at the sponsor institution and three had surgery at their home institution, then transferred tumor material to the sponsor institution. There were no differences between the two groups for potentially confounding variables such as neurosurgical procedure work relative value units (P = 0.13) or insurance provider (P = 0.26). There was no difference between the inpatient DCM per case for the institution for non-study patients (mean ± SD, $9039 ± $28,549) and study patients ($14,332 ± $20,231) (P = 0.4819). During the non-study period, there were a mean of 2.78 ± 1.65 pediatric brain tumor resections per month compared to 3.34 ± 1.66 cases per month during the study period, a 17% increase. When the 15 study patients were excluded, there were 2.97 ± 1.64 cases per month, a 7% increase. However, this increase in total case volume including study and non-study patients was not significant (P = 0.121). Phase I investigator-initiated surgically-based clinical trials may increase institutional surgical volume without imposing a financial burden. Finances are unlikely to be a barrier for researchers negotiating for resources to conduct such trials.

  9. Quality assurance in head and neck surgical oncology : EORTC 24954 trial on larynx preservation

    NARCIS (Netherlands)

    Leemans, C. R.; Tijink, B. M.; Langendijk, J. A.; Andry, G.; Hamoir, M.; Lefebvre, J. L.

    2013-01-01

    Background: The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment

  10. Control Group Design, Contamination and Drop-Out in Exercise Oncology Trials : A Systematic Review

    NARCIS (Netherlands)

    Bisschop, Charlotte N. Steins; Courneya, Kerry S.; Velthuis, Miranda J.; Monninkhof, Evelyn M.; Jones, Lee W.; Friedenreich, Christine; van der Wall, Elsken; Peeters, Petra H. M.; May, Anne M.

    2015-01-01

    Purpose Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-

  11. Application of Bayesian hierarchical models for phase I/II clinical trials in oncology.

    Science.gov (United States)

    Yada, Shinjo; Hamada, Chikuma

    2017-03-01

    Treatment during cancer clinical trials sometimes involves the combination of multiple drugs. In addition, in recent years there has been a trend toward phase I/II trials in which a phase I and a phase II trial are combined into a single trial to accelerate drug development. Methods for the seamless combination of phases I and II parts are currently under investigation. In the phase II part, adaptive randomization on the basis of patient efficacy outcomes allocates more patients to the dose combinations considered to have higher efficacy. Patient toxicity outcomes are used for determining admissibility to each dose combination and are not used for selection of the dose combination itself. In cases where the objective is not to find the optimum dose combination solely for efficacy but regarding both toxicity and efficacy, the need exists to allocate patients to dose combinations with consideration of the balance of existing trade-offs between toxicity and efficacy. We propose a Bayesian hierarchical model and an adaptive randomization with consideration for the relationship with toxicity and efficacy. Using the toxicity and efficacy outcomes of patients, the Bayesian hierarchical model is used to estimate the toxicity probability and efficacy probability in each of the dose combinations. Here, we use Bayesian moving-reference adaptive randomization on the basis of desirability computed from the obtained estimator. Computer simulations suggest that the proposed method will likely recommend a higher percentage of target dose combinations than a previously proposed method.

  12. Early oncology clinical trial design in the era of molecular-targeted agents.

    Science.gov (United States)

    Brunetto, Andre T; Kristeleit, Rebecca S; de Bono, Johann S

    2010-08-01

    The introduction of molecularly targeted agents has changed the concept of drug development. The field has evolved over the last decade and therapeutic drugs are now being rationally designed to affect specific intracellular or extracellular pathways that are thought to be important for cancer progression. Traditionally, toxicity has been the primary end point for dose definition and escalation; however, novel targeted compounds are characterized by the lack of significant clinical toxicity compared with conventional chemotherapy. Alternative trial designs and pharmacodynamic-driven biomarkers that assess drug-target effect and allow demonstration of proof-of-concept for intended target modulation and achievement of desired biological effects have emerged to guide dose selection. This must be facilitated by validated preclinical tumor models and biomarker assays that are critical to aid understanding of which agents are likely to be beneficial in different cancer subtype patients and which biomarkers should be implemented into early trial design.

  13. Clinical trials in pediatric neuro-oncology: what is missing and how we can improve.

    Science.gov (United States)

    Byer, Lennox; Kline, Cassie; Mueller, Sabine

    2016-10-01

    Brain tumors are the most common solid tumor in childhood, yet outcomes vary dramatically. High-grade gliomas have dismal outcomes with poor survival. By contrast, low-grade gliomas, have high survival rates, but children suffer from morbidity of tumor burden and therapy-associated side effects. In this article, we discuss how current trial designs often miss the opportunity to include end points beyond tumor response and thus fail to offer complete assessments of therapeutic approaches. Quality of life, neurocognitive function and neurofunctional deficits need to be considered when assessing overall success of a therapy. Herein, we identify specific end points that should be included in the interpretation of clinical trial results and accordingly, offer a more comprehensive approach to treatment decision-making.

  14. Phase I/II adaptive design for drug combination oncology trials

    OpenAIRE

    Wages, Nolan A.; Conaway, Mark R.

    2014-01-01

    Existing statistical methodology on dose finding for combination chemotherapies has focused on toxicity considerations alone in finding a maximum tolerated dose combination to recommend for further testing of efficacy in a phase II setting. Recently, there has been increasing interest in integrating phase I and phase II trials in order to facilitate drug development. In this article, we propose a new adaptive phase I/II method for dual-agent combinations that takes into account both toxicity ...

  15. Case management in oncology rehabilitation (CAMON: The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

    Directory of Open Access Journals (Sweden)

    Bardheci Katarina

    2011-04-01

    Full Text Available Abstract Background Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. Methods The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A. Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Discussion Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the

  16. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial.

    Science.gov (United States)

    Bakitas, Marie A; Tosteson, Tor D; Li, Zhigang; Lyons, Kathleen D; Hull, Jay G; Li, Zhongze; Dionne-Odom, J Nicholas; Frost, Jennifer; Dragnev, Konstantin H; Hegel, Mark T; Azuero, Andres; Ahles, Tim A

    2015-05-01

    Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60). Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority. © 2015 by American Society of Clinical Oncology.

  17. A multisite, community oncology-based randomized trial of a brief educational intervention to increase communication regarding complementary and alternative medicine.

    Science.gov (United States)

    Parker, Patricia A; Urbauer, Diana; Fisch, Michael J; Fellman, Bryan; Hough, Holly; Miller, Jessica; Lanzotti, Victor; Whisnant, Mindy; Weiss, Matthias; Fellenz, Lori; Bury, Martin; Kokx, Patricia; Finn, Kathleen; Daily, Maureen; Cohen, Lorenzo

    2013-10-01

    The use of complementary and alternative medicine (CAM) is widespread, yet there is relatively little discussion regarding its use between oncology patients and their health care practitioners. This multisite randomized trial examined the efficacy of an educational intervention designed to encourage oncology nurses to discuss CAM use with their patients. A total of 175 nurses completed questionnaires about discussing CAM use with patients at baseline and 2 months after the intervention. Patients at baseline (N = 699) and different patients at follow-up (N = 650) completed questionnaires regarding CAM. At the 2-month follow-up, nurses in the intervention reported they were more likely to ask about CAM use than those in the control group (odds ratio, 4.2; P = .005). However, no significant effect was found for the percentage of patients who indicated that they were asked about CAM use (odds ratio, 2.1; P > .10). Approximately 40% of patients reported using CAM after their cancer diagnosis, yet the majority of nurses estimated that < 25% of their patients were using CAM. CAM use in community-based oncology patients is common and is underestimated by oncology nurses. The brief, low-intensity intervention presented herein was found to be sufficiently powerful to change nurses' perceptions of their behavior but may not have been intensive enough to yield changes that were evident to patients. Copyright © 2013 UT MD Anderson Cancer Center. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

  18. Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens.

    Science.gov (United States)

    Maloney, Cristine; Lyons, Kathleen Doyle; Li, Zhongze; Hegel, Mark; Ahles, Tim A; Bakitas, Marie

    2013-04-01

    ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial. To gain a deeper understanding of participants' perspectives of the intervention and palliative care trial participation. A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation. Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation. Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve. The benefits of the intervention and the positive aspects of trial participation outweighed trial "burdens". This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?

  19. The Pittsburgh Breast Cancer Consortium

    Science.gov (United States)

    2005-08-01

    Protein Autovac in Patients with Brest Cancer CPharmexa). This trial was initiated in June 2003. The PBCC accrued 5 of the planned 11 patients. This...AD_________________ Award Number: DAMD17-01-1-0374 TITLE: The Pittsburgh Breast Cancer Consortium...3. DATES COVERED 1 AUG 2001 - 31 JUL 2005 4. TITLE AND SUBTITLE The Pittsburgh Breast Cancer Consortium 5a. CONTRACT NUMBER 5b. GRANT

  20. Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group.

    Science.gov (United States)

    Walter, S D; Cook, D J; Guyatt, G H; King, D; Troyan, S

    1997-02-01

    Considerable effort is often expended to adjudicate outcomes in clinical trials, but little has been written on the administration of the adjudication process and its possible impact on study results. As a case study, we describe the function and performance of an adjudication committee in a large randomized trial of two diagnostic approaches to potentially operable lung cancer. Up to five independent adjudicators independently determined two primary outcomes: tumor status at death or at final follow-up and the cause of death. Patients for whom there was any disagreement were discussed in committee until a consensus was achieved. We describe the pattern of agreement among the adjudicators and with the final consensus result. Additionally, we model the adjudication process and predict the results if a smaller committee had been used. We found that reducing the number of adjudicators from five to two or three would probably have changed the consensus outcome in less than 10% of cases. Correspondingly, the effect on the final study results (comparing primary outcomes in both randomized arms) would have been altered very little. Even using a single adjudicator would not have affected the results substantially. About 90 minutes of person-time per patient was required for activities directly related to the adjudication process, or approximately 6 months of full time work for the entire study. This level of effort could be substantially reduced by using fewer adjudicators with little impact on the results. Thus, we suggest that when high observer agreement is demonstrated or anticipated, adjudication committees should consist of no more than three members. Further work is needed to evaluate if smaller committees are adequate to detect small but important treatment effects or if they compromise validity when the level of adjudicator agreement is lower.

  1. End Points and Trial Design in Geriatric Oncology Research: A Joint European Organisation for Research and Treatment of Cancer–Alliance for Clinical Trials in Oncology–International Society of Geriatric Oncology Position Article

    National Research Council Canada - National Science Library

    Hans Wildiers; Murielle Mauer; Athanasios Pallis; Arti Hurria; Supriya G. Mohile; Andrea Luciani; Giuseppe Curigliano; Martine Extermann; Stuart M. Lichtman; Karla Ballman; Harvey Jay Cohen; Hyman Muss; Ulrich Wedding

    2013-01-01

    .... Well-established end points for clinical research exist in oncology but may not be as relevant to the older cancer population because of competing risks of death and potentially increased impact...

  2. Cancer patient and survivor research from the cancer information service research consortium: a preview of three large randomized trials and initial lessons learned.

    Science.gov (United States)

    Marcus, Alfred C; Diefenbach, Michael A; Stanton, Annette L; Miller, Suzanne M; Fleisher, Linda; Raich, Peter C; Morra, Marion E; Perocchia, Rosemarie Slevin; Tran, Zung Vu; Bright, Mary Anne

    2013-01-01

    The authors describe 3 large randomized trials from the Cancer Information Service Research Consortium. Three web-based multimedia programs are being tested to help newly diagnosed prostate (Project 1) and breast cancer patients (Project 2) make informed treatment decisions and breast cancer patients prepare for life after treatment (Project 3). Project 3 also tests a telephone callback intervention delivered by a cancer information specialist. All participants receive standard print material specific to each project. Preliminary results from the 2-month follow-up interviews are reported for the initial wave of enrolled participants, most of whom were recruited from the Cancer Information Service (1-800-4-CANCER) telephone information program (Project 1: n =208; Project 2: n =340; Project 3: n =792). Self-reported use of the multimedia program was 51%, 52%, and 67% for Projects 1, 2, and 3, respectively. Self-reported use of the print materials (read all, most, or some) was 90%, 85%, and 83% for Projects 1, 2, and 3, respectively. The callback intervention was completed by 92% of Project 3 participants. Among those using the Cancer Information Service Research Consortium interventions, perceived usefulness and benefit was high, and more than 90% reported that they would recommend them to other cancer patients. The authors present 5 initial lessons learned that may help inform future cancer communications research.

  3. Evaluation of the Effects of Music and Poetry in Oncologic Pain Relief: A Randomized Clinical Trial.

    Science.gov (United States)

    Arruda, Maurilene Andrade Lima Bacelar; Garcia, Marília Arrais; Garcia, João Batista Santos

    2016-09-01

    Various forms of art therapy have been tested as adjuvants in the treatment of physical and emotional disorders, including music and poetry. To evaluate the effect of passive listening to music and poetry on the variation in pain, depression, and hope scores. This was a randomized trial, with multiple aspects and an allocation ratio of 1:1:1, in which one group listened to music, one group listened to poetry, and another group received no intervention over a period of three days. A total of 75 adult patients experiencing pain and hospitalized in a cancer facility were included. The study was conducted over a period of three months. The primary outcome consisted of pain evaluation using a Visual Analog Scale, and the secondary outcomes consisted of evaluations of depression (Beck Depression Inventory) and hope (Herth Hope Scale). The final sample consisted of 65 participants, with 22 in the music group, 22 in the poetry group, and 21 controls. Music promoted an improvement in pain (p pain (p music and poetry groups and the control group after the study was only observed for the pain outcome (p music and poetry produced a similar improvement in the pain intensity. The two therapies also affected depression scores, and only poetry increased hope scores. Further investigation of the effects and comparisons between the two therapies should be performed.

  4. Perceptions of Cancer Care and Clinical Trials in the Black Community: Implications for Care Coordination Between Oncology and Primary Care Teams.

    Science.gov (United States)

    Sprague Martinez, Linda; Freeman, Elmer R; Winkfield, Karen M

    2017-07-13

    Despite efforts to ameliorate disparities in cancer care and clinical trials, barriers persist. As part of a multiphase community-engaged assessment, an exploratory community-engaged research partnership, forged between an academic hospital and a community-based organization, set out to explore perceptions of cancer care and cancer clinical trials by black Bostonians. Key informant interviews with health care providers and patient advocates in community health centers (CHCs), organizers from grassroots coalitions focused on cancer, informed the development of a focus group protocol. Six focus groups were conducted with black residents in Boston, including groups of cancer survivors and family members. Transcripts were coded thematically and a code-based report was generated and analyzed by community and academic stakeholders. While some participants identified clinical trials as beneficial, overall perceptions conjured feelings of fear and exploitation. Participants describe barriers to clinical trial participation in the context of cancer care experiences, which included negative interactions with providers and mistrust. Primary care physicians (PCPs) reported being levied as a trusted resource for patients undergoing care, but lamented the absence of a mechanism by which to gain information about cancer care and clinical trials. Confusion about cancer care and clinical trials persists, even among individuals who have undergone treatment for cancer. Greater coordination between PCPs and CHC care teams and oncology care teams may improve patient experiences with cancer care, while also serving as a mechanism to disseminate information about treatment options and clinical trials. Inequities in cancer care and clinical trial participation persist. Our findings indicate that greater coordination with primary care physicians (PCPs) and community health center (CHC) providers may be an important step for both improving the quality of cancer care in communities and

  5. Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1

    Science.gov (United States)

    Walcott, Farzana L.; Liu, Qing; Wickerham, D. Lawrence; Costantino, Joseph P.; Ganz, Patricia A.

    2016-01-01

    Background: Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations. Methods: P-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76–100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided. Results: Participants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity. Conclusions: Promoting QOL and managing symptoms early in therapy may be important strategies

  6. A comparison of calorie and protein intake in hospitalized pediatric oncology patients dining with a caregiver versus patients dining alone: a randomized, prospective clinical trial.

    Science.gov (United States)

    Williams, Ruth; Hinds, Pamela S; Ke, Weiming; Hu, X Joan

    2004-01-01

    Hospitalization and cancer therapy can contribute to decreased food intake in children and adolescents with cancer, making it a challenge to meet their nutritional needs. The affect of hospitalization and the eating environment for pediatric oncology patients has not been studied very well, and the effect of altering the social aspect of mealtime for hospitalized pediatric oncology patients has not been studied at all. The authors conducted a randomized, prospective clinical trial to determine if hospitalized pediatric oncology patients consume more protein and calories when eating with a family member or when eating alone in their room at mealtime. All food and beverage intake was recorded for 3 consecutive days, and a food service satisfaction survey was completed on Day 3. Food records were analyzed for calorie and protein intake, and surveys were analyzed for patient/parent satisfaction. The study was completed by 200 hospitalized patients and their parent/caregiver. Overall, neither calorie nor protein intake differed significantly between the two groups, but patient/parent satisfaction was significantly higher in the group of patients who dined with their caregiver. By using analysis of variance, the authors found that ideal body weight and years of sickness were significantly associated with calorie and protein intake.

  7. The organization of clinical trials for oncology at IRCCS Istituto Nazionale Tumori "Fondazione G. Pascale" Napoli and the impact of the OECI accreditation process.

    Science.gov (United States)

    De Feo, Gianfranco; D'Ambrosio, Francesca; Palmieri, Giada; Perrone, Francesco; Ciliberto, Gennaro

    2015-01-01

    The Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori "Fondazione G. Pascale" (INT-Pascale) is the largest Clinical Care and Research Cancer Center in Southern Italy. The mission is prevention, diagnosis, and care of cancer and innovative research in oncology. In 2013, INT-Pascale joined the Organisation of European Cancer Institutes (OECI) accreditation and classification project along with other Italian IRCCS cancer centers. One of the major OECI requirements that a cancer center must fulfill in order to achieve and maintain OECI certification is a strong emphasis in translational and clinical research: increasing the number of patients enrolled in clinical trials, establishing easily accessible databases for operators, and informing all possible stakeholders, including patients. A characterizing theme of INT-Pascale is a strong commitment to clinical experimental studies. In the 2007-2014 period, 440 clinical trials were activated at INT-Pascale; in this period, the number of clinical trials and observational studies has had an increment achieving in 2014, respectively, the share of 60 clinical trials and 35 observational studies activated. Optimization of clinical trials management and dissemination of the clinical research culture at INT-Pascale are main objectives to be achieved through several actions and procedures being implemented as a component of the OECI improvement plan. Participation in the OECI program has represented an important challenge to improve quality and processes related to promoting, prioritizing, and monitoring clinical trials at INT-Pascale.

  8. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01: Lessons learned

    Directory of Open Access Journals (Sweden)

    Daniel Pham

    2013-01-01

    Full Text Available Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment. Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated "help-desk" team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%, technical problems (46% while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support.

  9. Active surveillance: Oncologic outcome

    NARCIS (Netherlands)

    L.D.F. Venderbos (Lionne); L.P. Bokhorst (Leonard); C.H. Bangma (Chris); M.J. Roobol-Bouts (Monique)

    2013-01-01

    textabstractPURPOSE OF REVIEW: To give insight into recent literature (during the past 12-18 months) reporting on oncologic outcomes of men on active surveillance. RECENT FINDINGS: From recent published trials comparing radical prostatectomy vs. watchful waiting, we learn that radical treatment only

  10. Creating a unique, multi-stakeholder Paediatric Oncology Platform to improve drug development for children and adolescents with cancer.

    Science.gov (United States)

    Vassal, Gilles; Rousseau, Raphaël; Blanc, Patricia; Moreno, Lucas; Bode, Gerlind; Schwoch, Stefan; Schrappe, Martin; Skolnik, Jeffrey; Bergman, Lothar; Bradley-Garelik, Mary Brigid; Saha, Vaskar; Pearson, Andy; Zwierzina, Heinz

    2015-01-01

    Seven years after the launch of the European Paediatric Medicine Regulation, limited progress in paediatric oncology drug development remains a major concern amongst stakeholders - academics, industry, regulatory authorities, parents, patients and caregivers. Restricted increases in early phase paediatric oncology trials, legal requirements and regulatory pressure to propose early Paediatric Investigation Plans (PIPs), missed opportunities to explore new drugs potentially relevant for paediatric malignancies, lack of innovative trial designs and no new incentives to develop drugs against specific paediatric targets are some unmet needs. Better access to new anti-cancer drugs for paediatric clinical studies and improved collaboration between stakeholders are essential. The Cancer Drug Development Forum (CDDF), previously Biotherapy Development Association (BDA), with Innovative Therapy for Children with Cancer Consortium (ITCC), European Society for Paediatric Oncology (SIOPE) and European Network for Cancer Research in Children and Adolescents (ENCCA) has created a unique Paediatric Oncology Platform, involving multiple stakeholders and the European Union (EU) Commission, with an urgent remit to improve paediatric oncology drug development. The Paediatric Oncology Platform proposes to recommend immediate changes in the implementation of the Regulation and set the framework for its 2017 revision; initiatives to incentivise drug development against specific paediatric oncology targets, and repositioning of drugs not developed in adults. Underpinning these changes is a strategy for mechanism of action and biology driven selection and prioritisation of potential paediatric indications rather than the current process based on adult cancer indications. Pre-competitive research and drug prioritisation, early portfolio evaluation, cross-industry cooperation and multi-compound/sponsor trials are being explored, from which guidance for innovative trial designs will be

  11. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3: a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer to usual care, compared to usual care alone in patients with lung cancer

    Directory of Open Access Journals (Sweden)

    Sharpe Michael

    2009-09-01

    Full Text Available Abstract Background Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial will test its efficacy when compared to usual care alone. Design A two arm parallel group multi-centre randomised controlled trial. 200 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of lung cancer; an estimated life expectancy of three months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Lung Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is average depression severity. This will be assessed using scores on the 20-item Symptom Hopkins Checklist (SCL-20D, collected every four weeks over 32 weeks. Secondary outcomes include severity of anxiety, pain and fatigue; self-rated improvement of depression; quality of life and satisfaction with depression care. Trial Registration Current controlled trials ISRCTN75905964

  12. The MRI-Linear accelerator (MR-linac Consortium: evidence based clinical introduction of an innovation in radiation oncology connecting researchers, methodology, data collection, quality assurance and technical development

    Directory of Open Access Journals (Sweden)

    Linda G.W. Kerkmeijer

    2016-10-01

    Full Text Available An international research consortium has been formed to facilitate evidence-based introduction of MR-guided radiotherapy (MR-linac and to address how the MR-linac could be used to achieve an optimized radiation treatment approach to improve patients’ survival, local and regional tumor control, and quality of life. The present paper describes the organizational structure of the clinical part of the MR-linac consortium. Furthermore, it elucidates why collaboration on this large project is necessary and how a central data registry program will be implemented.

  13. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium.

    Science.gov (United States)

    Stone, Gregg W; Adams, David H; Abraham, William T; Kappetein, Arie Pieter; Généreux, Philippe; Vranckx, Pascal; Mehran, Roxana; Kuck, Karl-Heinz; Leon, Martin B; Piazza, Nicolo; Head, Stuart J; Filippatos, Gerasimos; Vahanian, Alec S

    2015-08-01

    Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of trans- catheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

  14. Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.

    Directory of Open Access Journals (Sweden)

    William R Mac Kenzie

    Full Text Available BACKGROUND: Tuberculosis Trials Consortium Study 28, was a double blind, randomized, placebo-controlled, phase 2 clinical trial examining smear positive pulmonary Mycobacterium tuberculosis. Over the course of intensive phase therapy, patients from African sites had substantially delayed and lower rates of culture conversion to negative in liquid media compared to non-African patients. We explored potential explanations of this finding. METHODS: In TBTC Study 28, protocol-correct patients (n = 328 provided spot sputum specimens for M. tuberculosis culture in liquid media, at baseline and weeks 2, 4, 6 and 8 of study therapy. We compared sputum culture conversion for African and non-African patients stratified by four baseline measures of disease severity: AFB smear quantification, extent of disease on chest radiograph, cavity size and the number of days to detection of M. tuberculosis in liquid media using the Kaplan-Meier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites. RESULTS: African TB patients had more extensive disease at enrollment than non-African patients. However, African patients with the least disease by the 4 measures of disease severity had conversion rates on liquid media that were substantially lower than conversion rates in non-African patients with the greatest extent of disease. HIV infection, smoking and diabetes did not explain delayed conversion in Africa. Some inter-site variation in laboratory processing and culture procedures within accepted practice for clinical diagnostic laboratories was found. CONCLUSIONS: Compared with patients from non-African sites, African patients being treated for TB had delayed sputum culture conversion and lower sputum conversion rates in liquid media that were not explained by baseline severity of disease, HIV status, age, smoking, diabetes or race. Further investigation is warranted into whether modest

  15. The reporting of adverse events in oncology phase III trials: a comparison of the current status versus the expectations of the EORTC members.

    Science.gov (United States)

    Maillet, D; Blay, J Y; You, B; Rachdi, A; Gan, H K; Péron, J

    2016-01-01

    Determination of drug safety and tolerability is usually based on the frequency of certain key adverse events (AEs) rather than the frequency of all-grade toxicities. We assessed the reporting of key AEs in oncology randomized, controlled trials (RCTs) and compared that with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership. RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of key AEs, namely: grade 3/4 AEs, grade 5 AEs, and AEs resulting in study withdrawal or in dose reduction. Study characteristics associated with better reporting of key AEs were investigated. Finally, a survey was conducted among the EORTC membership to determine their expectations on key AEs reporting. Although the frequency of grade 3/4 was reported in most reports (96%), only 17% of them described the reporting threshold above which grade 3/4 AEs were included for reporting, raising the possibility that important but less frequent grade 3/4 AEs might be underreported. Frequency and nature of grade 5 AEs were adequately reported in 161 (50%) of manuscripts; AEs leading to study withdrawal in 61 manuscripts (19%); and AEs leading to dose reduction in 43 manuscripts (13%). In contrast, most EORTC members expected a comprehensive reporting of grade 5 AEs (96% of EORTC member's responses), AEs leading to study withdrawal (86%) and AEs leading to dose reduction (70%). In multivariate analysis, frequencies of grade 5 AEs were less frequently reported in European trials (P = 0.004). Frequencies of AEs leading to withdrawals were more frequently reported in trials funded by industry (P = 0.005) and in trials including patients with breast or urological cancers (P = 0.006). These findings suggest that current practice of key AEs reporting remains highly variable and sometimes inadequate in oncology RCTs reports. Current standards for safety reporting in RCTs should be revised to emphasize the importance of key AEs

  16. Cancer Patient and Survivor Research from the Cancer Information Service Research Consortium: A Preview of Three Large Randomized Trials and Initial Lessons Learned

    Science.gov (United States)

    MARCUS, ALFRED C.; DIEFENBACH, MICHAEL A.; STANTON, ANNETTE L.; MILLER-HALEGOUA, SUZANNE N.; FLEISHER, LINDA; RAICH, PETER C.; MORRA, MARION E.; PEROCCHIA, ROSEMARIE SLEVIN; TRAN, ZUNG VU; BRIGHT, MARY ANNE

    2014-01-01

    Three large randomized trials are described from the Cancer Information Service Research Consortium (CISRC). Three web-based multimedia programs are being tested to help newly diagnosed prostate (Project 1) and breast cancer patients (Project 2) make informed treatment decisions and breast cancer patients prepare for life after treatment (Project 3). Project 3 is also testing a telephone callback intervention delivered by a cancer information specialist. All participants receive standard print material specific to each project. Preliminary results from the two-month follow-up interviews are reported for the initial wave of enrolled participants, most of whom were recruited from the Cancer Information Service (1-800-4-CANCER) telephone information program (Project 1 = 208, Project 2 = 340, Project 3 = 792). Self-reported use of the multimedia program was 51%, 52% and 67% for Projects 1–3, respectively. Self-reported use of the print materials (read all, most or some) was 90%, 85% and 83% for Projects 1–3, respectively. The callback intervention was completed by 92% of Project 3 participants. Among those using the CISRC interventions, perceived utility and benefit was high, and more than 90% would recommend them to other cancer patients. Five initial lessons learned are presented that may help inform future cancer communications research. PMID:23448232

  17. A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

    Science.gov (United States)

    Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

    2017-07-18

    The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

  18. Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological Puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients

    Directory of Open Access Journals (Sweden)

    Radeleff Boris

    2008-10-01

    Full Text Available Abstract Background Totally Implantable Access Ports (TIAP are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient. Design A single-center, expertise based randomized, controlled superiority trial to compare two different TIAP implantation techniques. 100 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective implantation of a TIAP under local anesthesia who signed the informed consent will be included. The primary endpoint is the primary success rate of the randomized technique. Control Intervention: Venae Sectio will be employed to insert a TIAP by a surgeon; Experimental intervention: Punction of V. Subclavia will be used to place a TIAP by a radiologist. Duration of study: Approximately 10 months, follow up time: 90 days. Organisation/Responsibility The PORTAS 2 – Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and Good Clinical Practice (GCP. The Center of Clinical Trials at the Department of Surgery, University Hospital Heidelberg is responsible for design and conduct of the trial including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI, University of Heidelberg. Trial Registration The trial is registered at ClinicalTrials.gov (NCT00600444.

  19. Computational oncology.

    Science.gov (United States)

    Lefor, Alan T

    2011-08-01

    Oncology research has traditionally been conducted using techniques from the biological sciences. The new field of computational oncology has forged a new relationship between the physical sciences and oncology to further advance research. By applying physics and mathematics to oncologic problems, new insights will emerge into the pathogenesis and treatment of malignancies. One major area of investigation in computational oncology centers around the acquisition and analysis of data, using improved computing hardware and software. Large databases of cellular pathways are being analyzed to understand the interrelationship among complex biological processes. Computer-aided detection is being applied to the analysis of routine imaging data including mammography and chest imaging to improve the accuracy and detection rate for population screening. The second major area of investigation uses computers to construct sophisticated mathematical models of individual cancer cells as well as larger systems using partial differential equations. These models are further refined with clinically available information to more accurately reflect living systems. One of the major obstacles in the partnership between physical scientists and the oncology community is communications. Standard ways to convey information must be developed. Future progress in computational oncology will depend on close collaboration between clinicians and investigators to further the understanding of cancer using these new approaches.

  20. A Phase 1 Trial of Imetelstat in Children with Refractory or Recurrent Solid Tumors: A Children’s Oncology Group Phase 1 Consortium Study (ADVL1112)

    Science.gov (United States)

    Thompson, Patrick A.; Drissi, Rachid; Muscal, Jodi A.; Panditharatna, Eshini; Fouladi, Maryam; Ingle, Ashish M.; Ahern, Charlotte H.; Reid, Joel M.; Lin, Tong; Weigel, Brenda J.; Blaney, Susan M.

    2014-01-01

    Purpose Imetelstat is a covalently-lipidated 13-mer thiophosphoramidate oligonucleotide that acts as a potent specific inhibitor of telomerase. It binds with high affinity to the template region of the RNA component of human telomerase (hTERC ) and is a competitive inhibitor of telomerase enzymatic activity. The purpose of this study was to determine the recommended phase 2 dose of imetelstat in children with recurrent or refractory solid tumors. Experimental Design Imetelstat was administered intravenously over two hours on days 1 and 8, every 21 days. Dose levels of 225, 285, and 360 mg/m2 were evaluated, using the rolling-six design. Imetelstat pharmacokinetic and correlative biology studies were also performed during the first cycle. Results Twenty subjects were enrolled (median age 14 yrs; range 3–21). Seventeen were evaluable for toxicity. The most common toxicities were neutropenia, thrombocytopenia, and lymphopenia, with dose-limiting myelosuppression in two of six patients at 360 mg/m2. Pharmacokinetics were dose dependent with a lower clearance at the highest dose level. Telomerase inhibition was observed in peripheral blood mononuclear cells at 285 and 360 mg/m2. Two confirmed partial responses osteosarcoma (n=1) and Ewing sarcoma (n=1) were observed. Conclusions The recommended phase 2 dose of imetelstat given on days 1 and 8 of 21-day cycle is 285 mg/m2. PMID:24097866

  1. Geriatric Oncology

    National Research Council Canada - National Science Library

    Helen Hughes; Vikram Swaminathan; Alice Pellegrini; Riccardo Audisio

    2014-01-01

    .... In this article, we review the current field of geriatric oncology. We highlight that age is not a contradiction to cancer treatment but geriatric assessment is needed to identify which treatment a patient may tolerate and benefit from.

  2. The business case for provider participation in clinical trials research: an application to the National Cancer Institute's community clinical oncology program.

    Science.gov (United States)

    Song, Paula H; Reiter, Kristin L; Weiner, Bryan J; Minasian, Lori; McAlearney, Ann Scheck

    2013-01-01

    Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. The aim of this study was to explore whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. We use a multiple case study methodology approach to examine the National Cancer Institute's community clinical oncology program, a long-standing federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semistructured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally funded PBRNs outside of oncology or to providers considering participation in any clinical trials research.

  3. Phase II trial of bryostatin-1 in combination with cisplatin in patients with recurrent or persistent epithelial ovarian cancer: a California cancer consortium study.

    Science.gov (United States)

    Morgan, Robert J; Leong, Lucille; Chow, Warren; Gandara, David; Frankel, Paul; Garcia, Agustin; Lenz, Heinz-Josef; Doroshow, James H

    2012-04-01

    The California Cancer Consortium has performed a Phase II trial of infusional bryostatin, a protein kinase C inhibitor isolated from the marine invertebrate bryozoan, Bugula Neritina, a member of the phylum Ectoprocta, in combination with cisplatin, in patients (pts) with recurrent platinum-sensitive or resistant ovarian cancer (OC). Pts received bryostatin 45 mcg/m(2) as a 72 h continuous infusion followed by cisplatin 50 mg/m(2). Cycles were repeated every 3 weeks. Dosages were chosen based on phase I data obtained by the CCC in a population of pts with mixed tumor types. Eight pts with recurrent or persistent epithelial OC received 23 cycles of treatment. All pts had received previous platinum-based chemotherapy; two pts had received one prior course, five had received two prior courses, and one had received three prior courses of chemotherapy. The median age was 64 (range 32-72), and Karnofsky performance status 90 (range 80-100). A median of 3 cycles of chemotherapy were delivered (range: 1-5). The median progression-free and overall survivals were 3 and 8.2 months respectively. Best responses included two partial responses (one in a platinum-resistant pt), three pts with stable disease, and three progressions. All pts experienced Grade 3 or 4 toxicities including severe myalgias/pain/fatigue/asthenia in six pts, and severe nausea/vomiting/constipation in two other pts. One pt experienced a seizure and liver function tests were elevated in one other. A modest response rate is observed in pts with recurrent or persistent ovarian cancer treated with the combination of bryostatin and cisplatin. The toxicity profile, however, observed in this pt population (primarily severe myalgias), precludes tolerability and prevents this combination from further investigation at this dose and schedule. It is possible that platinum pre-exposure in OC patients exacerbates observed toxicity. Phase II dosages of investigational agents in OC pts that are determined by phase I

  4. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium.

    Science.gov (United States)

    Stone, Gregg W; Vahanian, Alec S; Adams, David H; Abraham, William T; Borer, Jeffrey S; Bax, Jeroen J; Schofer, Joachim; Cutlip, Donald E; Krucoff, Mitchell W; Blackstone, Eugene H; Généreux, Philippe; Mack, Michael J; Siegel, Robert J; Grayburn, Paul A; Enriquez-Sarano, Maurice; Lancellotti, Patrizio; Filippatos, Gerasimos; Kappetein, Arie Pieter

    2015-08-01

    Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

  5. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium.

    Science.gov (United States)

    Stone, Gregg W; Vahanian, Alec S; Adams, David H; Abraham, William T; Borer, Jeffrey S; Bax, Jeroen J; Schofer, Joachim; Cutlip, Donald E; Krucoff, Mitchell W; Blackstone, Eugene H; Généreux, Philippe; Mack, Michael J; Siegel, Robert J; Grayburn, Paul A; Enriquez-Sarano, Maurice; Lancellotti, Patrizio; Filippatos, Gerasimos; Kappetein, Arie Pieter

    2015-07-21

    Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

    Directory of Open Access Journals (Sweden)

    Thoke-Colberg Anette

    2010-03-01

    Full Text Available Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII, 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT

  7. Body mass index and its association with clinical outcomes for advanced non-small-cell lung cancer patients enrolled on Eastern Cooperative Oncology Group clinical trials.

    Science.gov (United States)

    Dahlberg, Suzanne E; Schiller, Joan H; Bonomi, Philip B; Sandler, Alan B; Brahmer, Julie R; Ramalingam, Suresh S; Johnson, David H

    2013-09-01

    Obesity increases the risk of death from many adverse health outcomes and has also been linked with cancer outcomes. The impact of obesity on outcomes of advanced non-small-cell lung cancer patients is unclear. The authors evaluated the association of body mass index (BMI) and outcomes in 2585 eligible patients enrolled in three consecutive first-line trials conducted by the Eastern Cooperative Oncology Group. BMI was categorized as underweight (BMI obese (BMI ≥ 30 kg/m). In addition to analyzing overall and progression-free survival, reasons for treatment discontinuation were also assessed by BMI group. Of the patients enrolled, 4.6% were underweight, 44.1% were normal weight, 34.3% of patients were classified as overweight, and 16.9% were obese. Nonproportional hazards existed for obese patients relative to the other three groups of patients, with a change in overall survival hazard occurring at approximately 16 months. In multivariable Cox models, obese patients had superior outcomes earlier on study compared with normal/overweight patients 0.86 (HR=0.86, p=0.04; 95% CI: 0.75-0.99), but later experienced increased hazard (HR=1.54, p< 0.001; 95% CI: 1.22-1.94), indicating a time effect while undergoing treatment. Data from these three trials suggest differential outcomes associated with BMI, and additional studies of the mechanisms underlying this observation, as well as dietary and lifestyle interventions, are warranted to help optimize therapy.

  8. Combination goserelin and tamoxifen therapy in premenopausal advanced breast cancer: a multicentre study by the ITMO group. Italian Trials in Medical Oncology.

    Science.gov (United States)

    Buzzoni, R.; Biganzoli, L.; Bajetta, E.; Celio, L.; Fornasiero, A.; Mariani, L.; Zilembo, N.; Di Bartolomeo, M.; Di Leo, A.; Arcangeli, G.

    1995-01-01

    It has been suggested that tamoxifen may improve the efficacy of medical castration with luteinising hormone-releasing hormone analogues, but very few data have so far been published concerning the clinical and endocrinological activity of this therapeutic modality. In this phase II multicentre trial conducted by the Italian Trials in Medical Oncology group (ITMO), 64 premenopausal patients with hormone receptor-positive or unknown breast cancer were treated with monthly s.c. injections of goserelin 3.6 mg, in association with a tamoxifen daily dose of 20 mg, as first-line therapy for their advanced disease. All of the patients were evaluable for efficacy and there was an overall response rate of 41% (95% confidence interval 28-52%), with 7 of the 26 responders achieving complete remission. The median time to response was 4 months (range 2-17), and the median response duration was 13 months (range 6-37 +). Better responses were observed in soft tissues (51%); the response in visceral and bone metastases was respectively 19% and 37%. Serum concentrations of gonadotrophins and oestradiol were significantly decreased by the treatment, oestrogen levels being constantly suppressed to within the range observed in post-menopausal women. No significant change was detected in serum testosterone levels. In our experience, although it was not associated with any increased clinical efficacy, the concurrent use of goserelin and tamoxifen proved to be a feasible approach in the management of premenopausal advanced breast cancer. PMID:7734310

  9. International Lymphoma Epidemiology Consortium

    Science.gov (United States)

    The InterLymph Consortium, or formally the International Consortium of Investigators Working on Non-Hodgkin's Lymphoma Epidemiologic Studies, is an open scientific forum for epidemiologic research in non-Hodgkin's lymphoma.

  10. How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).

    Science.gov (United States)

    Milani, Alessandra; Mazzocco, Ketti; Stucchi, Sara; Magon, Giorgio; Pravettoni, Gabriella; Passoni, Claudia; Ciccarelli, Chiara; Tonali, Alessandra; Profeta, Teresa; Saiani, Luisa

    2017-02-01

    Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally.

  11. High-resolution manometry compared with the University of California, Los Angeles Scleroderma Clinical Trials Consortium GIT 2.0 in Systemic Sclerosis.

    Science.gov (United States)

    Abozaid, Hanan Sayed M; Imam, Hala M K; Abdelaziz, Marwa Mahmoud; El-Hammady, Dina H; Fathi, Nihal A; Furst, Daniel E

    2017-05-19

    To study esophageal high resolution manometry (HRM) in systemic sclerosis (SSc) patients and the correlation of findings to The University of California, Los Angeles Scleroderma Clinical Trials Consortium gastrointestinal tract 2.0 (UCLA SCTC_GIT 2.0). Forty SSc patients were administered to the UCLA SCTC GIT 2.0. Patients underwent HRM study (Solar GI MMS). HRM data were compared with 15 healthy volunteers. Forty patients with mean age 46 ± 7 years and disease duration 9.3 ± 7 years reported upper (85.7%), lower GI symptoms (75%), while 5% reported no symptoms. Mean ± SD scores of UCLA SCTC_GIT 2.0 items were as follows: reflux 1.2 ± 0.8, distention 1.6 ± 1.2, fecal soiling 0.3 ± 0.9, diarrhea 0.8 ± 1, social 1 ± 1, emotional 1 ± 1.1, constipation 0.5 ± 0.9, and total GIT score 0.9 ± 0.6. Lower esophageal sphincter (LES) pressure and distal esophageal amplitude were significantly lower in SSc patients than controls. Main manometric findings were decreased LES resting pressure (40%) and aperistalsis (40%). Regression analyses showed distal esophageal amplitude and LES resting pressure negatively correlated with reflux score (r = -0.64; p = 0.001 and r = -0.46; p = 0.019, respectively), and total GIT score (r = -0.54; p = 0.007 and r = -0.42; p = 0.03, respectively). LES resting pressure had negative correlations with diarrhea score (r = -0.062; p = 0.002). Decreased distal esophageal amplitude encountered as hypoperistalsis or even aperistalsis was associated with increased reflux and GIT scores (negatively correlated) UCLA SCTC_GIT 2.0 questionnaires. The GIT2.0 is easy to use and can serve as an indicator that further testing of the GI tract, including the esophagus, is indicated. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. When an interim analysis of randomized trial changes the practice in oncology: the lesson of adjuvant Trastuzumab and the HERA trial.

    Science.gov (United States)

    De Rossi, Costanza; Brunello, Antonella; Jirillo, Giuseppe; Jirillo, Antonio

    2009-03-01

    About 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.

  13. Time-to-event continual reassessment method incorporating treatment cycle information with application to an oncology phase I trial.

    Science.gov (United States)

    Huang, Bo; Kuan, Pei Fen

    2014-11-01

    Delayed dose limiting toxicities (i.e. beyond first cycle of treatment) is a challenge for phase I trials. The time-to-event continual reassessment method (TITE-CRM) is a Bayesian dose-finding design to address the issue of long observation time and early patient drop-out. It uses a weighted binomial likelihood with weights assigned to observations by the unknown time-to-toxicity distribution, and is open to accrual continually. To avoid dosing at overly toxic levels while retaining accuracy and efficiency for DLT evaluation that involves multiple cycles, we propose an adaptive weight function by incorporating cyclical data of the experimental treatment with parameters updated continually. This provides a reasonable estimate for the time-to-toxicity distribution by accounting for inter-cycle variability and maintains the statistical properties of consistency and coherence. A case study of a First-in-Human trial in cancer for an experimental biologic is presented using the proposed design. Design calibrations for the clinical and statistical parameters are conducted to ensure good operating characteristics. Simulation results show that the proposed TITE-CRM design with adaptive weight function yields significantly shorter trial duration, does not expose patients to additional risk, is competitive against the existing weighting methods, and possesses some desirable properties. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. Investigating the cost-effectiveness of videotelephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Theodoros Deborah

    2007-03-01

    Full Text Available Abstract Background Providing ongoing family centred support is an integral part of childhood cancer care. For families living in regional and remote areas, opportunities to receive specialist support are limited by the availability of health care professionals and accessibility, which is often reduced due to distance, time, cost and transport. The primary aim of this work is to investigate the cost-effectiveness of videotelephony to support regional and remote families returning home for the first time with a child newly diagnosed with cancer Methods/design We will recruit 162 paediatric oncology patients and their families to a single centre randomised controlled trial. Patients from regional and remote areas, classified by Accessibility/Remoteness Index of Australia (ARIA+ greater than 0.2, will be randomised to a videotelephone support intervention or a usual support control group. Metropolitan families (ARIA+ ≤ 0.2 will be recruited as an additional usual support control group. Families allocated to the videotelephone support intervention will have access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. Families in the usual support control group will receive standard care i.e., specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone for families who live far away from the hospital. The primary outcome measure is parental health related quality of life as measured using the Medical Outcome Survey (MOS Short Form SF-12 measured at baseline, 4 weeks, 8 weeks and 12 weeks. The secondary outcome measures are: parental informational and emotional support; parental perceived stress, parent reported patient quality of life and parent reported sibling quality of life, parental satisfaction

  15. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902

    Energy Technology Data Exchange (ETDEWEB)

    Rosenthal, Seth A., E-mail: rosents@sutterhealth.org [Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States); Hunt, Daniel [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Sartor, A. Oliver [Tulane University Medical Center, New Orleans, Louisiana (United States); Pienta, Kenneth J. [Johns Hopkins School of Medicine, Baltimore, Maryland (United States); Gomella, Leonard [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Grignon, David [Indiana University, Bloomington, Indiana (United States); Rajan, Raghu [McGill University, Montreal, Quebec (Canada); Kerlin, Kevin J. [Community Clinical Oncology Program, Southeast Cancer Control Consortium, Inc, Winston-Salem, North Carolina (United States); Jones, Christopher U. [Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States); Radiological Associates of Sacramento, Sacramento, California (United States); Dobelbower, Michael [University of Alabama at Birmingham Medical Center, Birmingham, Alabama (United States); Shipley, William U. [Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States); Zeitzer, Kenneth [Albert Einstein Medical Center, Bronx, New York (United States); Hamstra, Daniel A. [University of Michigan Medical Center, Ann Arbor, Michigan (United States); Donavanik, Viroon [Christiana Care Health Services, Inc, Wilmington, Delaware (United States); Rotman, Marvin [State University of New York Health Science Center–Brooklyn, Brooklyn, New York (United States); Hartford, Alan C. [Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States); Michalski, Jeffrey [Washington University, St. Louis, Missouri (United States); Seider, Michael [Akron City Hospital, Akron, Ohio (United States); Kim, Harold [Wayne State University, Detroit, Michigan (United States); and others

    2015-10-01

    Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS). Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20-100 ng/mL and Gleason score [GS] ≥7 or clinical stage ≥T2 and GS ≥8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05. Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P=.81), biochemical failure (58% vs 54%; P=.82), local progression (11% vs 7%; P=.09), distant metastases (16% vs 14%; P=.42), or disease-free survival (22% vs 26%; P=.61). Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for

  16. Radiogenomics Consortium (RGC)

    Science.gov (United States)

    The Radiogenomics Consortium's hypothesis is that a cancer patient's likelihood of developing toxicity to radiation therapy is influenced by common genetic variations, such as single nucleotide polymorphisms (SNPs).

  17. Phase II trial of the combination of bryostatin-1 and cisplatin in advanced or recurrent carcinoma of the cervix: a New York Gynecologic Oncology Group study.

    Science.gov (United States)

    Nezhat, Farr; Wadler, Scott; Muggia, Franco; Mandeli, John; Goldberg, Gary; Rahaman, Jamal; Runowicz, Carolyn; Murgo, Anthony J; Gardner, Ginger J

    2004-04-01

    Bryostatin-1 is a macrocyclic lactone that has been shown to regulate protein kinase C (PKC) activity and thereby potentially inhibit tumor invasion, angiogenesis, cell adhesion, and multidrug resistance. In preclinical experiments, bryostatin-1 induces tumor growth inhibition and enhances cytotoxicity when combined with other agents including cisplatin in cervical cancer cells. It was therefore anticipated that combination bryostatin-1-cisplatin therapy would be effective in patients with cervical cancer. The current study was conducted to evaluate this therapeutic approach in patients with recurrent or advanced-stage cervical carcinoma. An IRB-approved New York Gynecologic Oncology Group (NYGOG) trial was activated for patients with a histological diagnosis of metastatic cervical cancer or in patients with recurrent disease not eligible for surgery or radiation. Enrolled patients received bryostatin-1 (50-65 microg/m(2)) as a 1-h infusion followed by cisplatin (50 mg/m(2)). The combined treatment was administered every 21 days. Fourteen patients were enrolled. The majority of patients had squamous cell carcinoma. Ten out of fourteen patients had recurrent disease. Fifty percent of the patients received bryostatin at 50 microg/m(2) and 50% received bryostatin at 65 microg/m(2). Seventy-one percent completed two cycles of treatment. The most common grade II-III toxicities were myalgia, anemia, and nausea or vomiting. One patient developed a hypersensitivity reaction and one developed grade III nephrotoxicity. Seventy-one percent (10/14) of patients were evaluated for tumor response. Eight out of ten (80%) of patients had progressive disease and 2/10 (20%) had stable disease. There were no treatment responses. Despite promising preclinical data, this clinical trial indicates that the combination of cisplatin and bryostatin-1 at the doses and schedule used is not effective in patients with advanced-stage or recurrent cervical cancer. There is even the possibility of

  18. SU-E-P-26: Oncospace: A Shared Radiation Oncology Database System Designed for Personalized Medicine, Decision Support, and Research

    Energy Technology Data Exchange (ETDEWEB)

    Bowers, M; Robertson, S; Moore, J; Wong, J; DeWeese, T; McNutt, T [Johns Hopkins University, Baltimore, MD (United States); Phillips, M [Univ Washington, Seattle, WA (United States); Hendrickson, K [University of Washington, Seattle, WA (United States); Song, W; Kwok, P [Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, U of T, Toronto, Ontario (Canada)

    2015-06-15

    Purpose: Advancement in Radiation Oncology (RO) practice develops through evidence based medicine and clinical trial. Knowledge usable for treatment planning, decision support and research is contained in our clinical data, stored in an Oncospace database. This data store and the tools for populating and analyzing it are compatible with standard RO practice and are shared with collaborating institutions. The question is - what protocol for system development and data sharing within an Oncospace Consortium? We focus our example on the technology and data meaning necessary to share across the Consortium. Methods: Oncospace consists of a database schema, planning and outcome data import and web based analysis tools.1) Database: The Consortium implements a federated data store; each member collects and maintains its own data within an Oncospace schema. For privacy, PHI is contained within a single table, accessible to the database owner.2) Import: Spatial dose data from treatment plans (Pinnacle or DICOM) is imported via Oncolink. Treatment outcomes are imported from an OIS (MOSAIQ).3) Analysis: JHU has built a number of webpages to answer analysis questions. Oncospace data can also be analyzed via MATLAB or SAS queries.These materials are available to Consortium members, who contribute enhancements and improvements. Results: 1) The Oncospace Consortium now consists of RO centers at JHU, UVA, UW and the University of Toronto. These members have successfully installed and populated Oncospace databases with over 1000 patients collectively.2) Members contributing code and getting updates via SVN repository. Errors are reported and tracked via Redmine. Teleconferences include strategizing design and code reviews.3) Successfully remotely queried federated databases to combine multiple institutions’ DVH data for dose-toxicity analysis (see below – data combined from JHU and UW Oncospace). Conclusion: RO data sharing can and has been effected according to the Oncospace

  19. Individualized network-based drug repositioning infrastructure for precision oncology in the panomics era.

    Science.gov (United States)

    Cheng, Feixiong; Hong, Huixiao; Yang, Shengyong; Wei, Yuquan

    2016-06-12

    Advances in next-generation sequencing technologies have generated the data supporting a large volume of somatic alterations in several national and international cancer genome projects, such as The Cancer Genome Atlas and the International Cancer Genome Consortium. These cancer genomics data have facilitated the revolution of a novel oncology drug discovery paradigm from candidate target or gene studies toward targeting clinically relevant driver mutations or molecular features for precision cancer therapy. This focuses on identifying the most appropriately targeted therapy to an individual patient harboring a particularly genetic profile or molecular feature. However, traditional experimental approaches that are used to develop new chemical entities for targeting the clinically relevant driver mutations are costly and high-risk. Drug repositioning, also known as drug repurposing, re-tasking or re-profiling, has been demonstrated as a promising strategy for drug discovery and development. Recently, computational techniques and methods have been proposed for oncology drug repositioning and identifying pharmacogenomics biomarkers, but overall progress remains to be seen. In this review, we focus on introducing new developments and advances of the individualized network-based drug repositioning approaches by targeting the clinically relevant driver events or molecular features derived from cancer panomics data for the development of precision oncology drug therapies (e.g. one-person trials) to fully realize the promise of precision medicine. We discuss several potential challenges (e.g. tumor heterogeneity and cancer subclones) for precision oncology. Finally, we highlight several new directions for the precision oncology drug discovery via biotherapies (e.g. gene therapy and immunotherapy) that target the 'undruggable' cancer genome in the functional genomics era.

  20. Quality assurance standards drive improvements in the profile of radiation therapy departments participating in trials of the EORTC Radiation Oncology Group.

    Science.gov (United States)

    Grant, Warren; Hurkmans, Coen W; Poortmans, Philip M; Maingon, Philippe; Monti, Angelo F; van Os, Marjolein J H; Weber, Damien C

    2014-09-01

    The Facility Questionnaire (FQ) of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group (EORTC-ROG) evaluates the human, technical and organizational resources at each EORTC member institution. The purpose of this study is to use the FQ database to assess the improvement of radiation therapy (RT) structures and resources within the EORTC compared to the previous surveys performed by our group. We report the content of the current FQ database, completed online by 156 EORTC candidate member institutions from 22 countries between February 2011 and February 2013. Results are compared to FQ-published data from 1992 and 2007. The average number of patients per year per EORTC institution is 2381 (range 350-12,000) an 18.2% increase compared to the 2007 figures. From 2007 to 2013 the average number of radiation oncologists, physicists and radiation technologists per EORTC institution has increased by 27% (from 8.5 to 10.8), 41% (from 5.2 to 7.4) and 38% (from 26.1 to 36.1) respectively. Consequently the number of patients per year per radiation oncologist has decreased from 258 to 243, for physicists from 426 to 354 and for radiation technologists from 107 to 86. One hundred and forty-six (94%) and 101 (65%) institutions can now deliver IMRT and SBRT, compared to 77 (79%) and 53 (54%) in 2007. The standards set by the EORTC-ROG are met by a continually improving number of institutions, helping to safeguard use of advanced technologies in EORTC-ROG clinical trials. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Marginal prescription equivalent to the isocenter prescription in lung stereotactic body radiotherapy: preliminary study for Japan Clinical Oncology Group trial (JCOG1408)

    Science.gov (United States)

    Kawahara, Daisuke; Ozawa, Shuichi; Kimura, Tomoki; Saito, Akito; Nishio, Teiji; Nakashima, Takeo; Ohno, Yoshimi; Murakami, Yuji; Nagata, Yasushi

    2017-01-01

    A new randomized Phase III trial, the Japan Clinical Oncology Group (JCOG) 1408, which compares two dose fractionations (JCOG 0403 and JCOG 0702) for medically inoperable Stage IA NSCLC or small lung lesions clinically diagnosed as primary lung cancer, involves the introduction of a prescribed dose to the D95% of the planning target volume (PTV) using a superposition/convolution algorithm. Therefore, we must determine the prescribed dose in the D95% prescribing method to begin JCOG1408. JCOG 0702 uses density correction and the D95% prescribing method. However, JCOG 0403 uses no density correction and isocenter- prescribing method. The purpose of this study was to evaluate the prescribed dose to the D95% of the PTV equivalent to a dose of 48 Gy to the isocenter (JCOG 0403) using a superposition algorithm. The peripheral isodose line, which has the highest conformity index, and the D95% of the PTV were analyzed by considering the weighting factor, i.e. the inverse of the difference between the doses obtained using the superposition and Clarkson algorithms. The average dose at the isodose line of the highest conformity index and the D95% of the PTV were 41.5 ± 0.3 and 42.0 ± 0.3 Gy, respectively. The D95% of the PTV had a small correlation with the target volume (r2 = 0.0022) and with the distance between the scatterer and tumor volumes (r2 = 0.19). Thus, the prescribed dose of 48 Gy using the Clarkson algorithm (JCOG0403) was found to be equivalent to the prescribed dose of 42 Gy to the D95% of the PTV using the superposition algorithm. PMID:28115532

  2. Healthcare Costs Reduced After Incorporating the Results of the American College of Surgeons Oncology Group Z0011 Trial into Clinical Practice.

    Science.gov (United States)

    Fillion, Michelle M; Glass, Katherine E; Hayek, Joe; Wehr, Allison; Phillips, Gary; Terando, Alicia; Agnese, Doreen M

    2016-11-30

    The purpose of our study was to quantitate the changes in axillary lymph node dissection (ALND), frozen section (FS), and the impact on costs after the publication of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial. We compared axillary nodal management and cost data in breast cancer patients who met Z0011 criteria and were treated with lumpectomy and sentinel lymph nodes (SLN) biopsy from 2007 to July 2013. Of 800 patients, 67 (13.5%) and 34 (12.5%) patients in the pre- and post-Z0011 era had 1-2 positive SLN. ALND decreased from 78% to 21% (p < 0.001) after publication of Z0011. The mean overall cost of SLN biopsy was $41,059 per patient, while SLN biopsy with completion ALND was $50,999 (p < 0.001). Intraoperative FS use decreased from 95% to 66% (p = 0.015). Omitting the FS decreased mean costs from $4,319 to $2,036. The application of Z0011 resulted in an overall mean cost savings of $571,653 from 2011 to July 2013. ACOSOG Z0011 significantly impacted axillary management resulting in a 20% reduction in the mean overall cost per patient by omitting ALND. In these patients, intraoperative FS analysis had poor sensitivity (56%) and doubled the cost of pathologic examination. Fewer ALND and intraoperative FS were performed after the publication of ACOSOG Z0011. Eliminating FS and ALND in patients who met Z0011 criteria, results in significant cost savings.

  3. Subcutaneous versus intravenous granulocyte colony stimulating factor for the treatment of neutropenia in hospitalized hemato-oncological patients: randomized controlled trial.

    Science.gov (United States)

    Paul, Mical; Ram, Ron; Kugler, Eitan; Farbman, Laura; Peck, Anat; Leibovici, Leonard; Lahav, Meir; Yeshurun, Moshe; Shpilberg, Ofer; Herscovici, Corina; Wolach, Ofir; Itchaki, Gilad; Bar-Natan, Michal; Vidal, Liat; Gafter-Gvili, Anat; Raanani, Pia

    2014-03-01

    Intravenous (IV) granulocyte colony stimulating factor (G-CSF) might be safer and more convenient than subcutaneous (SC) administration to hospitalized hemato-oncological patients receiving chemotherapy. To compare IV vs. SC G-CSF administration, we conducted a randomized, open-label trial. We included inpatients receiving chemotherapy for acute myeloid leukemia, acute lymphoblastic leukemia, lymphoma or multiple myeloma, and allogeneic or autologous hematopoietic cell transplantation (HCT). Patients were randomized to 5 mcg/kg single daily dose of IV bolus versus SC filgrastim given for its clinical indications. Patients were crossed-over to the alternate study arm on the subsequent chemotherapy course. The primary outcomes were time from initiation of filgrastim to recovery of stable neutrophil count of >500 cells/µL and a composite clinical outcome of infection or death assessed for the first course post-randomization. The study was stopped on the second interim analysis. Of 120 patients randomized, 118 were evaluated in the first treatment course. The mean time to neutropenia resolution was longer with IV G-CSF [7.9 days, 95% confidence interval (CI) 6.6-9.1] compared with SC G-CSF (5.4 days, 95% CI 4.6-6.2), log-rank P = 0.001. Longer neutropenia duration was observed in all patient subgroups, except for patients undergoing autologous HCT. There was no significant difference between groups in the occurrence of infection or death, but more deaths were observed with IV (4/57, 7%) versus SC (1/61, 1.6%) G-CSF administration, P = 0.196. Similar results were observed when all 158 courses following cross-over were analyzed. Patients reported similar pain and satisfaction scores in both groups. Bolus IV administration of G-CSF results in longer neutropenia duration than SC administration, with no difference in clinical or quality-of-life measures.

  4. ICONE: An International Consortium of Neuro Endovascular Centres.

    Science.gov (United States)

    Raymond, J; White, P; Kallmes, D F; Spears, J; Marotta, T; Roy, D; Guilbert, F; Weill, A; Nguyen, T; Molyneux, A J; Cloft, H; Cekirge, S; Saatci, I; Bracard, S; Meder, J F; Moret, J; Cognard, C; Qureshi, A I; Turk, A S; Berenstein, A

    2008-06-30

    The proliferation of new endovascular devices and therapeutic strategies calls for a prudentand rational evaluation of their clinical benefit. This evaluation must be done in an effective manner and in collaboration with industry. Such research initiative requires organisation a land methodological support to survive and thrive in a competitive environment. We propose the formation of an international consortium, an academic alliance committed to the pursuit of effective neurovascular therapies. Such a consortium would be dedicated to the designand execution of basic science, device developmentand clinical trials. The Consortium is owned and operated by its members. Members are international leaders in neurointerventional research and clinical practice. The Consortium brings competency, knowledge, and expertise to industry as well as to its membership across aspectrum of research initiatives such as: expedited review of clinical trials, protocol development, surveys and systematic reviews; laboratory expertise and support for research design and grant applications to public agencies. Once objectives and protocols are approved, the Consortium provides a stable network of centers capable of timely realization of clinical trials or pre clinical investigations in an optimal environment. The Consortium is a non-profit organization. The potential revenue generated from clientsponsored financial agreements will be redirected to the academic and research objectives of the organization. The Consortium wishes to work inconcert with industry, to support emerging trends in neurovascular therapeutic development. The Consortium is a realistic endeavour optimally structured to promote excellence through scientific appraisal of our treatments, and to accelerate technical progress while maximizing patients' safety and welfare.

  5. Phase II/III trial of etoposide and high-dose ifosfamide in newly diagnosed metastatic osteosarcoma: a pediatric oncology group trial.

    Science.gov (United States)

    Goorin, Allen M; Harris, Michael B; Bernstein, Mark; Ferguson, William; Devidas, Meenakshi; Siegal, Gene P; Gebhardt, Mark C; Schwartz, Cindy L; Link, Michael; Grier, Holcombe E

    2002-01-15

    The objectives of this trial were to estimate the response rate, progression-free survival, and overall survival of patients who received therapy with etoposide and high-dose ifosfamide, and to define the toxicity of this combination when provided with standard chemotherapy in patients with newly diagnosed metastatic osteosarcoma. Eligible patients received infusions of 100 mg/m(2) per day of etoposide and 3.5 g/m(2) per day of ifosfamide for 5 days. Therapy with granulocyte colony-stimulating factor was begun on day 6. This was repeated 3 weeks after therapy was begun. Response was determined at week 6 by both standard World Health Organization response criteria and by pathologic determination of tumor necrosis of the primary tumor. Forty-three patients were registered; 39 were assessable for response and 41 for toxicity and survival. Twenty-eight (68%) of 41 had metastatic sites only in the lung; 12 (29%) had metastatic sites in other bones with or without lung involvement. Four patients (10%) experienced complete response, and 19 patients (49%) experienced partial response, for an overall response rate of 59% +/- 8%. The projected 2-year progression-free survival (PFS) for the 28 patients with metastases to lungs was 39% +/- 11%. The projected 2-year PFS for the 12 patients with metastases to other bones (with or without pulmonary metastases) was 58% +/- 17%. Two patients died as a result of therapy toxicity. Eighty-three percent of patients had grade 4 neutropenia, and 29% had grade 4 thrombocytopenia. Ten patients (24%) had sepsis. Fanconi's syndrome was observed in five patients. The combination of etoposide and high-dose ifosfamide is effective induction chemotherapy for patients with metastatic osteosarcoma, despite significant associated myelosuppression sometimes complicated by infection and renal toxicity.

  6. Erectile Function and Oncologic Outcomes Following Open Retropubic and Robot-assisted Radical Prostatectomy: Results from the LAParoscopic Prostatectomy Robot Open Trial.

    Science.gov (United States)

    Sooriakumaran, Prasanna; Pini, Giovannalberto; Nyberg, Tommy; Derogar, Maryam; Carlsson, Stefan; Stranne, Johan; Bjartell, Anders; Hugosson, Jonas; Steineck, Gunnar; Wiklund, Peter N

    2017-09-04

    Whether surgeons perform better utilising a robot-assisted laparoscopic technique compared with an open approach during prostate cancer surgery is debatable. To report erectile function and early oncologic outcomes for both surgical modalities, stratified by prostate cancer risk grouping. In a prospective nonrandomised trial, we recruited 2545 men with prostate cancer from seven open (n=753) and seven robot-assisted (n=1792) Swedish centres (2008-2011). Clinometrically-validated questionnaire-based patient-reported erectile function was collected before, 3 mo, 12 mo, and 24 mo after surgery. Surgeon-reported degree of neurovascular-bundle preservation, pathologist-reported positive surgical margin (PSM) rates, and 2-yr prostate-specific antigen-relapse rates were measured. Among 1702 preoperatively potent men, we found enhanced erectile function recovery for low/intermediate-risk patients in the robot-assisted group at 3 mo. For patients with high-risk tumours, point estimates for erectile function recovery at 24 mo favoured the open surgery group. The degree of neurovascular bundle preservation and erectile function recovery were greater correlated for robot-assisted surgery. In pT2 tumours, 10% versus 17% PSM rates were observed for open and robot-assisted surgery, respectively; corresponding rates for pT3 tumours were 48% and 33%. These differences were associated with biochemical recurrence in pT3 but not pT2 disease. The study is limited by its nonrandomised design and relatively short follow-up. Earlier recovery of erectile function in the robot-assisted surgery group in lower-risk patients is counterbalanced by lower PSM rates for open surgeons in organ-confined disease; thus, both open and robotic surgeons need to consider this trade-off when determining the plane of surgical dissection. Robot-assisted surgery also facilitates easier identification of nerve preservation planes during radical prostatectomy as well as wider dissection for pT3 cases. For

  7. Cell Line Derived Multi-Gene Predictor of Pathologic Response to Neoadjuvant Chemotherapy in Breast Cancer: A Validation Study on US Oncology 02-103 Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shen Kui

    2012-11-01

    Full Text Available Abstract Background The purpose of this study is to assess the predictive accuracy of a multi-gene predictor of response to docetaxel, 5-fluorouracil, epirubicin and cyclophosphamide combination chemotherapy on gene expression data from patients who received these drugs as neoadjuvant treatment. Methods Tumor samples were obtained from patients with stage II-III breast cancer before starting neoadjuvant chemotherapy with four cycles of 5-fluorouracil/epirubicin/cyclophosphamide (FEC followed by four cycles of docetaxel/capecitabine (TX on US Oncology clinical trial 02-103. Most patients with HER-2-positive cancer also received trastuzumab (H. The chemotherapy predictor (TFEC-MGP was developed from publicly available gene expression data of 42 breast cancer cell-lines with corresponding in vitro chemotherapy sensitivity results for the four chemotherapy drugs. No predictor was developed for treatment with trastuzumab. The predictive performance of TFEC-MGP in distinguishing cases with pathologic complete response from those with residual disease was evaluated for the FEC/TX and FEC/TX plus H group separately. The area under the receiver-operating characteristic curve (AU-ROC was used as the metric of predictive performance. Genomic predictions were performed blinded to clinical outcome. Results The AU-ROC was 0.70 (95% CI: 0.57-0.82 for the FEC/TX group (n=66 and 0.43 (95% CI: 0.20-0.66 for the FEC/TX plus H group (n=25. Among the patients treated with FEC/TX, the AU-ROC was 0.69 (95% CI: 0.52-0.86 for estrogen receptor (ER-negative (n=28 and it was 0.59 (95% CI: 0.36-0.82 for ER-positive cancers (n=37. ER status was not reported for one patient. Conclusions Our results indicate that the cell line derived 291-probeset genomic predictor of response to FEC/TX combination chemotherapy shows good performance in a blinded validation study, particularly in ER-negative patients.

  8. The BADER Consortium

    Science.gov (United States)

    2013-10-01

    officials and UD Alumni. Senators Coons and Carper and Representative Carney also attended. Dr. Stanhope travelled to Capitol Hill to visit the...offices of Senators Coons (D-DE) and Carper (D-DE). The briefing meetings resulted in plans for a spring BADER Consortium event on the Hill and a visit...Spaulding Rehabilitation Hospital Davis, Samuel, PhD BADER Consortium Affiliate Naval Medical Center Portsmouth (NMCP) de Lateur, Barbara J., MD, MS

  9. Research and development project of regional consortiums in fiscal 1998. Research and development of regional consortium energy (development of measuring technology to aid energy conservation in electronic device manufacturing processes (design and trial production of IMI) (Report on the result in the first year)); 1998 nendo chiiki consortium energy kenkyu kaihatsu. Denshi kikirui seizo process no sho energy shien keisoku seigyo gijutsu no kaihatsu (IMI no sekkei to shisaku) (dai 1 nendo)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-03-01

    This paper summarizes the development of intelligent micro instruments (IMI) inaugurated in fiscal 1998 as the wide-area consortium project for the Tama area. Research and development will be carried out on the following items: IMI substrate elements utilizing micro machining technology, applicable to micro sensors and micro probes, semiconductor process sensors, electronic device measuring probes, signal processing and communication circuits for wireless sensing. This paper describes the achievements during fiscal 1998. Technologies were transferred from the Mechanical Engineering Laboratory of the Agency of Industrial Science and Technology on silicon micro machining and PZT piezoelectric thin film formation. An IMI research laboratory was installed at the Tokyo Metropolitan University. In developing the IMI substrate elements, different beams applicable to sensors and probes were fabricated on a trial basis, and their mechanical properties were measured. For the semiconductor process sensors, discussions were given on micronization on a chlorine ion analyzer. In developing the electronic device measuring probes, the target was placed on measurement of in-situ characteristics of IC chips on a wafer. A prototype transmitting and receiving circuit board was fabricated for developing the wireless sensing. (NEDO)

  10. Personalized oncology

    DEFF Research Database (Denmark)

    Tuxen, Ida Viller; Jønson, Lars; Santoni-Rugiu, Eric;

    2014-01-01

    accelerated drug development. The overall advantage is to determine which mutation profiles correlate with sensitivity or lack of resistance to specific targeted therapies. The utility and current limitations of genomic screening to guide selection to Phase 1 clinical trial will be discussed....

  11. [Shared web-based data center for multi-institutional clinical trials: evaluation of UMIN-INDICE (university hospital medical information network-internet data and information center for medical research)in clinical trials of JIVROSG (Japan interventional radiology in oncology study group)].

    Science.gov (United States)

    Sone, Miyuki; Arai, Yasuaki; Kiuchi, Takahiro; Ishikawa, Hirono; Aoki, Noriaki; Inaba, Yoshitaka; Yoshioka, Tetsuya; Aramaki, Takeshi; Kobayashi, Takeshi; Matsuoka, Toshiyuki; Anai, Hiroshi; Tanigawa, Noboru; Osuga, Keigo; Takeuchi, Yoshito; Okusaka, Takushi; Kanazawa, Susumu; Matsui, Osamu; Endo, Keigo

    2012-04-01

    A patient registration system is mandatory for establishing the scientific credibility of the multi-center clinical trials. The Japan Interventional Radiology in Oncology Study Group (JIVROSG) was organized in 2002 to establish evidence supporting the procedures used in interventional radiology. The Internet Data and Information Center for Medical Research (INDICE), provided by the University Hospital Medical Information Network(UMIN), has been utilized for patient registration in the clinical trials of JIVROSG. In this study, the safety and efficacy of UMIN-INDICE were evaluated. From 2002 to 2010, 18 clinical trials, including one international trial, were conducted. A total of 736 patients were enrolled from 51 institutions. No significant trouble was encountered during this period. A questionnaire survey demonstrated that 90% of participating researchers could use this system without difficulties. UMIN-INDICE may contribute to promoting clinical trials as an infrastructure of multicenter studies.

  12. Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

    Science.gov (United States)

    Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

    2017-10-06

    Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Prevention of central venous catheter-associated bloodstream infections in paediatric oncology patients using 70% ethanol locks : A randomised controlled multi-centre trial

    NARCIS (Netherlands)

    Schoot, Reineke A.; van Ommen, C. Heleen; Stijnen, Theo; Tissing, Wim J. E.; Michiels, Erna; Abbink, Floor C. H.; Raphael, Martine F.; Heij, Hugo A.; Lieverst, Jan A.; Spanjaard, Lodewijk; Zwaan, C. Michel; Caron, Huib N.; van de Wetering, Marianne D.

    Background: The prevention of central venous catheter (CVC) associated bloodstream infections (CABSIs) in paediatric oncology patients is essential. Ethanol locks can eliminate pathogens colonising CVCs and microbial resistance is rare. Aim of this study was to determine whether two hour 70% ethanol

  14. Leptomeningeal metastasis: A Response Assessment in Neuro-Oncology critical review of endpoints and response criteria of published randomized clinical trials

    NARCIS (Netherlands)

    M.C. Chamberlain (Marc C.); R. Soffietti; J. Raizer; R. Rudà (Roberta); D. Brandsma (Dieta); W. Boogerd (Willem); S. Taillibert; M.D. Groves (Morris D.); E. Le Rhun (Emilie); L. Junck (L.); M.J. van den Bent (Martin); P.Y. Wen (Patrick); K. Jaeckle (K.)

    2014-01-01

    textabstractPurpose. To date, response criteria and optimal methods for assessment of outcome have not been standardized in patients with leptomeningeal metastasis (LM). Methods. A Response Assessment in Neuro-Oncology working group of experts in LM critically reviewed published literature regarding

  15. Leptomeningeal metastasis: A Response Assessment in Neuro-Oncology critical review of endpoints and response criteria of published randomized clinical trials

    NARCIS (Netherlands)

    M.C. Chamberlain (Marc C.); R. Soffietti; J. Raizer; R. Rudà (Roberta); D. Brandsma (Dieta); W. Boogerd (Willem); S. Taillibert; M.D. Groves (Morris D.); E. Le Rhun (Emilie); L. Junck (L.); M.J. van den Bent (Martin); P.Y. Wen (Patrick); K. Jaeckle (K.)

    2014-01-01

    textabstractPurpose. To date, response criteria and optimal methods for assessment of outcome have not been standardized in patients with leptomeningeal metastasis (LM). Methods. A Response Assessment in Neuro-Oncology working group of experts in LM critically reviewed published literature regarding

  16. Nanotechnology in radiation oncology.

    Science.gov (United States)

    Wang, Andrew Z; Tepper, Joel E

    2014-09-10

    Nanotechnology, the manipulation of matter on atomic and molecular scales, is a relatively new branch of science. It has already made a significant impact on clinical medicine, especially in oncology. Nanomaterial has several characteristics that are ideal for oncology applications, including preferential accumulation in tumors, low distribution in normal tissues, biodistribution, pharmacokinetics, and clearance, that differ from those of small molecules. Because these properties are also well suited for applications in radiation oncology, nanomaterials have been used in many different areas of radiation oncology for imaging and treatment planning, as well as for radiosensitization to improve the therapeutic ratio. In this article, we review the unique properties of nanomaterials that are favorable for oncology applications and examine the various applications of nanotechnology in radiation oncology. We also discuss the future directions of nanotechnology within the context of radiation oncology. © 2014 by American Society of Clinical Oncology.

  17. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium.

    Science.gov (United States)

    Stone, Gregg W; Adams, David H; Abraham, William T; Kappetein, Arie Pieter; Généreux, Philippe; Vranckx, Pascal; Mehran, Roxana; Kuck, Karl-Heinz; Leon, Martin B; Piazza, Nicolo; Head, Stuart J; Filippatos, Gerasimos; Vahanian, Alec S

    2015-07-21

    Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

  18. A phase I/II trial of the histone deacetylase inhibitor romidepsin for adults with recurrent malignant glioma: North American Brain Tumor Consortium Study 03-03.

    Science.gov (United States)

    Iwamoto, Fabio M; Lamborn, Kathleen R; Kuhn, John G; Wen, Patrick Y; Yung, W K Alfred; Gilbert, Mark R; Chang, Susan M; Lieberman, Frank S; Prados, Michael D; Fine, Howard A

    2011-05-01

    Romidepsin, a potent histone deacetylase inhibitor, has shown activity in preclinical glioma models. The primary objectives of this trial were to determine the pharmacokinetics of romidepsin in patients with recurrent glioma on enzyme-inducing antiepileptic drugs (EIAEDs) and to evaluate the antitumor efficacy of romidepsin in patients with recurrent glioblastoma who were not receiving EIAEDs. Two dose cohorts were studied in the phase I component of the trial (13.3 and 17.7 mg/m(2)/d). Patients in the phase II component were treated with intravenous romidepsin at a dosage of 13.3 mg/m(2)/day on days 1, 8, and 15 of each 28-day cycle. Eight patients were treated on the phase I component. A similar romidepsin pharmacokinetic profile was demonstrated between patients receiving EIAEDs to those not receving EIAEDs. Thirty-five patients with glioblastoma were accrued to the phase II component. There was no objective radiographic response. The median progression-free survival (PFS) was 8 weeks and only 1 patient had a PFS time ≥6 months (PFS6 = 3%). To date, 34 patients (97%) have died, with a median survival duration of 34 weeks. Despite in vitro studies showing that romidepsin is primarily metabolized by CYP3A4, no decrease in exposure to romidepsin was seen in patients receiving potent CYP3A4 inducers. Romidepsin, at its standard dose and schedule, was ineffective for patients with recurrent glioblastomas. ClinicalTrials.gov identifier: NCT00085540.

  19. Southwest Oncology Group S0008: A Phase III Trial of High-Dose Interferon Alfa-2b Versus Cisplatin, Vinblastine, and Dacarbazine, Plus Interleukin-2 and Interferon in Patients With High-Risk Melanoma—An Intergroup Study of Cancer and Leukemia Group B, Children's Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group

    Science.gov (United States)

    Flaherty, Lawrence E.; Othus, Megan; Atkins, Michael B.; Tuthill, Ralph J.; Thompson, John A.; Vetto, John T.; Haluska, Frank G.; Pappo, Alberto S.; Sosman, Jeffrey A.; Redman, Bruce G.; Moon, James; Ribas, Antoni; Kirkwood, John M.; Sondak, Vernon K.

    2014-01-01

    Purpose High-dose interferon (IFN) for 1 year (HDI) is the US Food and Drug Administration–approved adjuvant therapy for patients with high-risk melanoma. Efforts to modify IFN dose and schedule have not improved efficacy. We sought to determine whether a shorter course of biochemotherapy would be more effective. Patients and Methods S0008 (S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma) was an Intergroup phase III trial that enrolled high-risk patients (stage IIIA-N2a through IIIC-N3), randomly assigning them to receive either HDI or biochemotherapy consisting of dacarbazine, cisplatin, vinblastine, interleukin-2, IFN alfa-2b (IFN-α-2b) and granulocyte colony-stimulating factor given every 21 days for three cycles. Coprimary end points were relapse-free survival (RFS) and overall survival (OS). Results In all, 432 patients were enrolled. Grade 3 and 4 adverse events occurred in 57% and 7% of HDI patients and 36% and 40% of biochemotherapy patients, respectively. At a median follow-up of 7.2 years, biochemotherapy improved RFS (hazard ratio [HR], 0.75; 95% CI, 0.58 to 0.97; P = .015), with a median RFS of 4.0 years (95% CI, 1.9 years to not reached [NR]) versus 1.9 years for HDI (95% CI, 1.2 to 2.8 years) and a 5-year RFS of 48% versus 39%. Median OS was not different (HR, 0.98; 95% CI, 0.74 to 1.31; P = .55), with a median OS of 9.9 years (95% CI, 4.62 years to NR) for biochemotherapy versus 6.7 years (95% CI, 4.5 years to NR) for HDI and a 5-year OS of 56% for both arms. Conclusion Biochemotherapy is a shorter, alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in RFS but no difference in OS and more toxicity compared with HDI. PMID:25332243

  20. Updates from the 2013 Society for Neuro-Oncology annual and World Federation for Neuro-Oncology quadrennial meeting.

    Science.gov (United States)

    Lukas, Rimas V; Amidei, Christina

    2014-01-01

    We present an overview of a number of key clinical studies in infiltrating gliomas presented at the 2013 Society for Neuro-Oncology and World Federation of Neuro-Oncology joint meeting. This review focuses on efficacy results, including quality of life studies, from larger clinical trials in both high- and low-grade infiltrating gliomas.

  1. Neuro-oncology: a selected review of ASCO 2016 abstracts.

    Science.gov (United States)

    Chamberlain, Marc C

    2016-10-01

    ASCO 2016, 29 May-2 June 2016, Chicago, IL, USA The largest annual clinical oncology conference the American Society of Clinical Oncology is held in the USA and gives researchers and other key opinion leaders the opportunity to present new cancer clinical trials and research data. The CNS tumors section of the American Society of Clinical Oncology 2016 covered various aspects of neuro-oncology including metastatic CNS diseases and primary brain tumors, presented via posters, oral talks and over 100 abstracts. This brief review selectively highlights presentations from this meeting in an organizational manner that reflects clinically relevant aspects of a large and multifaceted meeting.

  2. Insufficiency Fractures After Pelvic Radiation Therapy for Uterine Cervical Cancer: An Analysis of Subjects in a Prospective Multi-institutional Trial, and Cooperative Study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG)

    Energy Technology Data Exchange (ETDEWEB)

    Tokumaru, Sunao, E-mail: tokumaru@cc.saga-u.ac.jp [Department of Heavy Particle Therapy and Radiation Oncology, Saga University, Saga (Japan); Toita, Takafumi [Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa (Japan); Oguchi, Masahiko [Radiation Oncology Department, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo (Japan); Ohno, Tatsuya [Gunma University Heavy Ion Medical Center, Maebashi (Japan); Kato, Shingo [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Niibe, Yuzuru [Department of Radiology, School of Medicine, Kitasato University, Sagamihara (Japan); Kazumoto, Tomoko [Department of Radiology, Saitama Cancer Center, Saitama (Japan); Kodaira, Takeshi [Department of Radiation Oncology, Aichi Cancer Center, Nagoya (Japan); Kataoka, Masaaki [Department of Radiology, National Shikoku Cancer Center, Matsuyama (Japan); Shikama, Naoto [Department of Radiation Oncology, Saitama Medical University, International Medical Center, Saitama (Japan); Kenjo, Masahiro [Department of Radiation Oncology, Graduate School of Medical Science, Hiroshima University, Hiroshima (Japan); Yamauchi, Chikako [Department of Radiation Oncology, Shiga Medical Center for Adults, Moriyama (Japan); Suzuki, Osamu [Department of Radiation Oncology, Osaka Medical Center for Cancer, Osaka (Japan); Sakurai, Hideyuki [Proton Medical Research Center and Tsukuba University, Tuskuba (Japan); Teshima, Teruki [Department of Medical Physics and Engineering, Graduate School of Medicine, Osaka University, Suita (Japan); Kagami, Yoshikazu [Department of Radiology, Showa University School of Medicine, Tokyo (Japan); Nakano, Takashi [Department of Radiation Oncology, Gunma University, Graduate School of Medicine, Maebashi (Japan); Hiraoka, Masahiro [Department of Radiation Oncology and Image-applied Therapy, Kyoto University, Graduate School of Medicine, Kyoto (Japan); and others

    2012-10-01

    Purpose: To investigate pelvic insufficiency fractures (IF) after definitive pelvic radiation therapy for early-stage uterine cervical cancer, by analyzing subjects of a prospective, multi-institutional study. Materials and Methods: Between September 2004 and July 2007, 59 eligible patients were analyzed. The median age was 73 years (range, 37-84 years). The International Federation of Gynecologic Oncology and Obstetrics stages were Ib1 in 35, IIa in 12, and IIb in 12 patients. Patients were treated with the constant method, which consisted of whole-pelvic external-beam radiation therapy of 50 Gy/25 fractions and high-dose-rate intracavitary brachytherapy of 24 Gy/4 fractions without chemotherapy. After radiation therapy the patients were evaluated by both pelvic CT and pelvic MRI at 3, 6, 12, 18, and 24 months. Diagnosis of IF was made when the patients had both CT and MRI findings, neither recurrent tumor lesions nor traumatic histories. The CT findings of IF were defined as fracture lines or sclerotic linear changes in the bones, and MRI findings of IF were defined as signal intensity changes in the bones, both on T1- and T2-weighted images. Results: The median follow-up was 24 months. The 2-year pelvic IF cumulative occurrence rate was 36.9% (21 patients). Using Common Terminology Criteria for Adverse Events version 3.0, grade 1, 2, and 3 IF were seen in 12 (21%), 6 (10%), and 3 patients (5%), respectively. Sixteen patients had multiple fractures, so IF were identified at 44 sites. The pelvic IF were frequently seen at the sacroileal joints (32 sites, 72%). Nine patients complained of pain. All patients' pains were palliated by rest or non-narcotic analgesic drugs. Higher age (>70 years) and low body weight (<50 kg) were thought to be risk factors for pelvic IF (P=.007 and P=.013, Cox hazard test). Conclusions: Cervical cancer patients with higher age and low body weight may be at some risk for the development of pelvic IF after pelvic radiation therapy.

  3. Kansas Wind Energy Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Gruenbacher, Don [Kansas State Univ., Manhattan, KS (United States)

    2015-12-31

    This project addresses both fundamental and applied research problems that will help with problems defined by the DOE “20% Wind by 2030 Report”. In particular, this work focuses on increasing the capacity of small or community wind generation capabilities that would be operated in a distributed generation approach. A consortium (KWEC – Kansas Wind Energy Consortium) of researchers from Kansas State University and Wichita State University aims to dramatically increase the penetration of wind energy via distributed wind power generation. We believe distributed generation through wind power will play a critical role in the ability to reach and extend the renewable energy production targets set by the Department of Energy. KWEC aims to find technical and economic solutions to enable widespread implementation of distributed renewable energy resources that would apply to wind.

  4. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.

    Science.gov (United States)

    Barker, A D; Sigman, C C; Kelloff, G J; Hylton, N M; Berry, D A; Esserman, L J

    2009-07-01

    I-SPY 2 (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2) is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers. The framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer. I-SPY 2 is a collaborative effort among academic investigators, the National Cancer Institute, the US Food and Drug Administration, and the pharmaceutical and biotechnology industries under the auspices of the Foundation for the National Institutes of Health Biomarkers Consortium.

  5. Acute oncological emergencies.

    LENUS (Irish Health Repository)

    Gabriel, J

    2012-01-01

    The number of people receiving systemic anti-cancer treatment and presenting at emergency departments with treatment-related problems is rising. Nurses will be the first point of contact for most patients and need to be able to recognise oncological emergencies to initiate urgent assessment of patients and referral to the acute oncology team so that the most appropriate care can be delivered promptly. This article discusses the role of acute oncology services, and provides an overview of the most common acute oncological emergencies.

  6. Protection of quality and innovation in radiation oncology: The prospective multicenter trial the German Society of Radiation Oncology (DEGRO-QUIRO study). Evaluation of time, attendance of medical staff, and resources during radiotherapy with IMRT

    Energy Technology Data Exchange (ETDEWEB)

    Vorwerk, H.; Schiller, R. [University of Marburg, Department of Radiotherapy and Radiooncology, Marburg (Germany); Zink, K.; Engenhart-Cabillic, R. [University of Marburg, Department of Radiotherapy and Radiooncology, Marburg (Germany); University of Giessen, Department of Radiotherapy and Radiooncology, Giessen (Germany); Budach, V.; Boehmer, D. [Charite, University of Berlin, Department of Radiotherapy and Radiooncology, Berlin (Germany); Kampfer, S. [Technische Universitaet Muenchen, Department of Radiation-Oncology, Muenchen (Germany); Popp, W. [Prime Networks AG, Basel (Switzerland); Sack, H. [University of Essen, Department of Radiotherapy and Radiooncology, Essen (Germany)

    2014-05-15

    A number of national and international societies published recommendations regarding the required equipment and manpower assumed to be necessary to treat a number of patients with radiotherapy. None of these recommendations were based on actual time measurements needed for specific radiotherapy procedures. The German Society of Radiation Oncology (DEGRO) was interested in substantiating these recommendations by prospective evaluations of all important core procedures of radiotherapy in the most frequent cancers treated by radiotherapy. The results of the examinations of radiotherapy with intensity-modulated radiation therapy (IMRT) in patients with different tumor entities are presented in this manuscript. Four radiation therapy centers [University Hospital of Marburg, University Hospital of Giessen, University Hospital of Berlin (Charite), Klinikum rechts der Isar der Technischen Universitaet Muenchen] participated in this prospective study. The workload of the different occupational groups and room occupancies for the core procedures of radiotherapy were prospectively documented during a 2-month period per center and subsequently statistically analyzed. The time needed per patient varied considerably between individual patients and between centers for all the evaluated procedures. The technical preparation (contouring of target volume and organs at risk, treatment planning, and approval of treatment plan) was the most time-consuming process taking 3 h 54 min on average. The time taken by the medical physicists for this procedure amounted to about 57 %. The training part of the preparation time was 87 % of the measured time for the senior physician and resident. The total workload for all involved personnel comprised 74.9 min of manpower for the first treatment, 39.7 min for a routine treatment with image guidance, and 22.8 min without image guidance. The mean room occupancy varied between 10.6 min (routine treatment without image guidance) and 23.7 min (first

  7. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  8. Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02)

    Science.gov (United States)

    Iwamoto, Fabio M.; Lamborn, Kathleen R.; Robins, H. Ian; Mehta, Minesh P.; Chang, Susan M.; Butowski, Nicholas A.; DeAngelis, Lisa M.; Abrey, Lauren E.; Zhang, Wei-Ting; Prados, Michael D.; Fine, Howard A.

    2010-01-01

    The objective of this phase II single-arm study was to evaluate the efficacy and safety of pazopanib, a multi-targeted tyrosine kinase inhibitor, against vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, platelet-derived growth factor receptor-α and -β, and c-Kit, in recurrent glioblastoma. Patients with ≤2 relapses and no prior anti-VEGF/VEGFR therapy were treated with pazopanib 800 mg daily on 4-week cycles without planned interruptions. Brain magnetic resonance imaging and clinical reassessment were made every 8 weeks. The primary endpoint was efficacy as measured by 6-month progression-free survival (PFS6). Thirty-five GBM patients with a median age of 53 years and median Karnofsky performance scale of 90 were accrued. Grade 3/4 toxicities included leukopenia (n = 1), lymphopenia (n = 2), thrombocytopenia (n = 1), ALT elevation (n = 3), AST elevation (n = 1), CNS hemorrhage (n = 1), fatigue (n = 1), and thrombotic/embolic events (n = 3); 8 patients required dose reduction. Two patients had a partial radiographic response by standard bidimensional measurements, whereas 9 patients (6 at the 8-week point and 3 only within the first month of treatment) had decreased contrast enhancement, vasogenic edema, and mass effect but <50% reduction in tumor. The median PFS was 12 weeks (95% confidence interval [CI]: 8–14 weeks) and only 1 patient had a PFS time ≥6 months (PFS6 = 3%). Thirty patients (86%) had died and median survival was 35 weeks (95% CI: 24–47 weeks). Pazopanib was reasonably well tolerated with a spectrum of toxicities similar to other anti-VEGF/VEGFR agents. Single-agent pazopanib did not prolong PFS in this patient population but showed in situ biological activity as demonstrated by radiographic responses. ClinicalTrials.gov identifier: NCT00459381. PMID:20200024

  9. A phase II study of medroxyprogesterone acetate in patients with hormone receptor negative metastatic breast cancer: translational breast cancer research consortium trial 007.

    Science.gov (United States)

    Miller, Kathy D; Althouse, Sandra K; Nabell, Lisle; Rugo, Hope; Carey, Lisa; Kimmick, Gretchen; Jones, David R; Merino, Maria J; Steeg, Patricia S

    2014-11-01

    Preclinical data suggest that medroxyprogesterone acetate (MPA) has both anti-metastatic and anti-angiogenic activity in the absence of hormone receptors (HR). This phase II trial assessed the activity of MPA alone or in combination with low-dose chemotherapy in patients with metastatic HR-negative breast cancer. Postmenopausal women with HR-negative disease were eligible if they had not received more than 3 chemotherapy regimens for metastatic disease. All patients were treated with MPA 1,000-1,500 mg/day orally; patients in cohort two also received low-dose oral cyclophosphamide and methotrexate (ldCM, 50 mg/day and 2.5 mg twice daily on Days 1 and 2 each week). Tissue and circulating biomarkers were assessed serially. The primary endpoint was clinical benefit response defined as objective response or stable disease >6 months. Thirty patients were enrolled (14 MPA monotherapy; 16 MPA + ldCM); median age was 55 (35-80); nearly all had visceral involvement. Despite dose escalation in 90 % of patients, only 17 (57 %) patients ever achieved MPA trough concentrations >50 ng/ml. One patient developed grade 4 renal failure in the setting of rapid disease progression and dehydration. There were no objective responses. One patient in each cohort (~7 %) had stable disease for > 6 months. Skin Nm23 expression increased after 4 weeks of MPA + ldCM, but there were no significant changes in TSP-1, PAI-1 antigen, or PAI-1 activity. MPA had limited activity and does not warrant further development in patients with HR-negative advanced breast cancer. Poor bioavailability limited exposure despite dose escalation.

  10. Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Collins, Sean [Department of Radiation Oncology, Georgetown University, Washington, District of Columbia (United States); Fuller, Donald [Genesis Healthcare Partners, San Diego, California (United States); Wang, Pin-Chieh; Kupelian, Patrick; Steinberg, Michael [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Katz, Alan [Flushing Radiation Oncology, Flushing, New York (United States)

    2013-12-01

    Purpose: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Methods and Materials: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Results: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Conclusion: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.

  11. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group.

    Science.gov (United States)

    Lichtman, Stuart M; Harvey, R Donald; Damiette Smit, Marie-Anne; Rahman, Atiqur; Thompson, Michael A; Roach, Nancy; Schenkel, Caroline; Bruinooge, Suanna S; Cortazar, Patricia; Walker, Dana; Fehrenbacher, Louis

    2017-10-02

    Purpose Patients with organ dysfunction, prior or concurrent malignancies, and comorbidities are often excluded from clinical trials. Excluding patients on the basis of these factors results in clinical trial participants who are healthier and younger than the overall population of patients with cancer. Methods ASCO and Friends of Cancer Research established a multidisciplinary working group that included experts in trial design and conduct to examine how eligibility criteria could be more inclusive. The group analyzed current eligibility criteria; conducted original data analysis; considered safety concerns, potential benefits, research, and potential hurdles of this approach through discussion; and reached consensus on recommendations regarding updated eligibility criteria that prioritize inclusiveness without compromising patient safety. Results If renal toxicity and clearance are not of direct treatment-related concern, then patients with lower creatinine clearance values of > 30 mL/min should be included in trials. Inclusion of patients with mild to moderate hepatic dysfunction may be possible when the totality of the available nonclinical and clinical data indicates that inclusion is safe. Ejection fraction values should be used with investigator assessment of a patient's risk for heart failure to determine eligibility. Patients with laboratory parameters out of normal range as a result of hematologic disease should be included in trials. Measures of patient functional status should be included in trials to better assess fit versus frail patients. Conclusion Expanding inclusion of these patients will increase the number and diversity of patients in clinical trials and result in a more appropriate population of patients.

  12. Impact of Intensity-Modulated Radiation Therapy Technique for Locally Advanced Non-Small-Cell Lung Cancer: A Secondary Analysis of the NRG Oncology RTOG 0617 Randomized Clinical Trial.

    Science.gov (United States)

    Chun, Stephen G; Hu, Chen; Choy, Hak; Komaki, Ritsuko U; Timmerman, Robert D; Schild, Steven E; Bogart, Jeffrey A; Dobelbower, Michael C; Bosch, Walter; Galvin, James M; Kavadi, Vivek S; Narayan, Samir; Iyengar, Puneeth; Robinson, Clifford G; Wynn, Raymond B; Raben, Adam; Augspurger, Mark E; MacRae, Robert M; Paulus, Rebecca; Bradley, Jeffrey D

    2017-01-01

    Purpose Although intensity-modulated radiation therapy (IMRT) is increasingly used to treat locally advanced non-small-cell lung cancer (NSCLC), IMRT and three-dimensional conformal external beam radiation therapy (3D-CRT) have not been compared prospectively. This study compares 3D-CRT and IMRT outcomes for locally advanced NSCLC in a large prospective clinical trial. Patients and Methods A secondary analysis was performed to compare IMRT with 3D-CRT in NRG Oncology clinical trial RTOG 0617, in which patients received concurrent chemotherapy of carboplatin and paclitaxel with or without cetuximab, and 60- versus 74-Gy radiation doses. Comparisons included 2-year overall survival (OS), progression-free survival, local failure, distant metastasis, and selected Common Terminology Criteria for Adverse Events (version 3) ≥ grade 3 toxicities. Results The median follow-up was 21.3 months. Of 482 patients, 53% were treated with 3D-CRT and 47% with IMRT. The IMRT group had larger planning treatment volumes (median, 427 v 486 mL; P = .005); a larger planning treatment volume/volume of lung ratio (median, 0.13 v 0.15; P = .013); and more stage IIIB disease (30.3% v 38.6%, P = .056). Two-year OS, progression-free survival, local failure, and distant metastasis-free survival were not different between IMRT and 3D-CRT. IMRT was associated with less ≥ grade 3 pneumonitis (7.9% v 3.5%, P = .039) and a reduced risk in adjusted analyses (odds ratio, 0.41; 95% CI, 0.171 to 0.986; P = .046). IMRT also produced lower heart doses ( P < .05), and the volume of heart receiving 40 Gy (V40) was significantly associated with OS on adjusted analysis ( P < .05). The lung V5 was not associated with any ≥ grade 3 toxicity, whereas the lung V20 was associated with increased ≥ grade 3 pneumonitis risk on multivariable analysis ( P = .026). Conclusion IMRT was associated with lower rates of severe pneumonitis and cardiac doses in NRG Oncology clinical trial RTOG 0617, which supports

  13. Ophthalmic epidemiology in Europe : the "European Eye Epidemiology" (E3) consortium

    NARCIS (Netherlands)

    Delcourt, Cecile; Korobelnik, Jean-Francois; Buitendijk, Gabrielle H. S.; Foster, Paul J.; Hammond, Christopher J.; Piermarocchi, Stefano; Peto, Tunde; Jansonius, Nomdo; Mirshahi, Alireza; Hogg, Ruth E.; Bretillon, Lionel; Topouzis, Fotis; Deak, Gabor; Grauslund, Jakob; Broe, Rebecca; Souied, Eric H.; Creuzot-Garcher, Catherine; Sahel, Jose; Daien, Vincent; Lehtimaki, Terho; Hense, Hans-Werner; Prokofyeva, Elena; Oexle, Konrad; Rahi, Jugnoo S.; Cumberland, Phillippa M.; Schmitz-Valckenberg, Steffen; Fauser, Sascha; Bertelsen, Geir; Hoyng, Carel; Bergen, Arthur; Silva, Rufino; Wolf, Sebastian; Lotery, Andrew; Chakravarthy, Usha; Fletcher, Astrid; Klaver, Caroline C. W.

    The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170,000

  14. Ophthalmic epidemiology in Europe : the "European Eye Epidemiology" (E3) consortium

    NARCIS (Netherlands)

    Delcourt, Cecile; Korobelnik, Jean-Francois; Buitendijk, Gabrielle H. S.; Foster, Paul J.; Hammond, Christopher J.; Piermarocchi, Stefano; Peto, Tunde; Jansonius, Nomdo; Mirshahi, Alireza; Hogg, Ruth E.; Bretillon, Lionel; Topouzis, Fotis; Deak, Gabor; Grauslund, Jakob; Broe, Rebecca; Souied, Eric H.; Creuzot-Garcher, Catherine; Sahel, Jose; Daien, Vincent; Lehtimaki, Terho; Hense, Hans-Werner; Prokofyeva, Elena; Oexle, Konrad; Rahi, Jugnoo S.; Cumberland, Phillippa M.; Schmitz-Valckenberg, Steffen; Fauser, Sascha; Bertelsen, Geir; Hoyng, Carel; Bergen, Arthur; Silva, Rufino; Wolf, Sebastian; Lotery, Andrew; Chakravarthy, Usha; Fletcher, Astrid; Klaver, Caroline C. W.

    2016-01-01

    The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170,000 Europea

  15. Oncology Advanced Practitioners Bring Advanced Community Oncology Care.

    Science.gov (United States)

    Vogel, Wendy H

    2016-01-01

    Oncology care is becoming increasingly complex. The interprofessional team concept of care is necessary to meet projected oncology professional shortages, as well as to provide superior oncology care. The oncology advanced practitioner (AP) is a licensed health care professional who has completed advanced training in nursing or pharmacy or has completed training as a physician assistant. Oncology APs increase practice productivity and efficiency. Proven to be cost effective, APs may perform varied roles in an oncology practice. Integrating an AP into an oncology practice requires forethought given to the type of collaborative model desired, role expectations, scheduling, training, and mentoring.

  16. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials.

    Science.gov (United States)

    London, Wendy B; Bagatell, Rochelle; Weigel, Brenda J; Fox, Elizabeth; Guo, Dongjing; Van Ryn, Collin; Naranjo, Arlene; Park, Julie R

    2017-09-08

    Early-phase trials in patients with recurrent neuroblastoma historically used an objective "response" of measureable disease (Response Evaluation Criteria In Solid Tumors [RECIST], without bone/bone marrow assessment) to select agents for further study. Historical cohorts may be small and potentially biased; to the authors' knowledge, disease recurrence studies from international registries are outdated. Using a large recent cohort of patients with recurrent/refractory neuroblastoma from Children's Oncology Group (COG) modern-era early-phase trials, the authors determined outcome and quantified parameters for designing future studies. The first early-phase COG trial enrollment (sequential) of 383 distinct patients with recurrent/refractory neuroblastoma on 23 phase 1, 3 phase 1/2, and 9 phase 2 trials (August 2002 to January 2014) was analyzed for progression-free survival (PFS), overall survival (OS), and time to disease progression (TTP). Planned frontline therapy for patients with high-risk neuroblastoma included hematopoietic stem cell transplantation (approximately two-thirds of patients underwent ≥1 hematopoietic stem cell transplantation); 13.2% of patients received dinutuximab. From the time of the patient's first early-phase trial enrollment (383 patients), the 1-year and 4-year PFS rates ( ± standard error) were 21% ± 2% and 6% ± 1%, respectively, whereas the 1-year and 4-year OS rates were 57% ± 3% and 20% ± 2%, respectively. The median TTP was 58 days (interquartile range, 31-183 days [350 patients]); the median follow-up was 25.3 months (33 patients were found to be without disease recurrence/progression). The median time from diagnosis to first disease recurrence/progression was 18.7 months (range, 1.4-64.8 months) (176 patients). MYCN amplification and 11q loss of heterozygosity were prognostic of worse PFS and OS (P = .003 and Pphase trial enrollment. This recent COG cohort of patients with recurrent

  17. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    Energy Technology Data Exchange (ETDEWEB)

    Gaze, Mark N., E-mail: mark.gaze@uclh.nhs.uk [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Boterberg, Tom [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Dieckmann, Karin; Hoermann, Marcus [General Hospital Vienna, Medical University Vienna (Austria); Gains, Jennifer E.; Sullivan, Kevin P. [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Ladenstein, Ruth [Children' s Cancer Research Institute, St. Anna Children' s Hospital, Vienna (Austria)

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  18. The Neuroscience Peer Review Consortium

    Directory of Open Access Journals (Sweden)

    Maunsell John HR

    2009-03-01

    Full Text Available Abstract As the Neuroscience Peer Review Consortium (NPRC ends its first year, it is worth looking back to see how the experiment has worked. In order to encourage dissemination of the details outlined in this Editorial, it will also be published in other journals in the Neuroscience Peer Review Consortium.

  19. Identifying oncological emergencies.

    Science.gov (United States)

    Guddati, Achuta K; Kumar, Nilay; Segon, Ankur; Joy, Parijat S; Marak, Creticus P; Kumar, Gagan

    2013-01-01

    Prompt identification and treatment of life-threatening oncological conditions is of utmost importance and should always be included in the differential diagnosis. Oncological emergencies can have a myriad of presentations ranging from mechanical obstruction due to tumor growth to metabolic conditions due to abnormal secretions from the tumor. Notably, hematologic and infectious conditions may complicate the presentation of oncological emergencies. Advanced testing and imaging is generally required to recognize these serious presentations of common malignancies. Early diagnosis and treatment of these conditions can significantly affect the patient's clinical outcome.

  20. Do all patients in the phase I oncology trials need to be hospitalized? Domestic but outstanding issues for globalization of drug development in Japan.

    Science.gov (United States)

    Shimomura, Akihiko; Kondo, Shunsuke; Kobayashi, Noriko; Iwasa, Satoru; Kitano, Shigehisa; Tamura, Kenji; Fujiwara, Yutaka; Yamamoto, Noboru

    2017-08-01

    Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment. Study designs were classified into three types: first-in-human (FIH) study, dose-escalation study (conventional dose-escalation study to determine maximum tolerated dose (MTD) in Japanese patients), and dose-finding study (to assess safety and pharmacokinetic profiles up to the MTD previously determined in the West). A total of 945 patients who participated in a variety of single-agent phase I clinical trials between December 1996 and August 2014 were included in this study. Patients participated in one of three study types: dose-escalation (n = 582, 62%), first-in-human (n = 129, 14%), or dose-finding (n = 234, 25%). A total of 76 study drugs were evaluated as part of this pool of phase I studies. Subdivided by mechanism of action, 20 (26%) were cytotoxic, 50 (66%) were molecularly targeted, and 6 (8%) were immune checkpoint inhibitor. Thirty-six patients (3.8%) had severe toxicities requiring hospitalization during the first cycle. The overall number of toxicities requiring hospitalization and/or grade 4 toxicities during any cycle was 5.0%. The frequency of severe toxicity that needs to be hospitalized was unexpectedly low. The data did not demonstrate the need for hospitalization in the phase I trials, suggesting that phase I trials in Japan could be conducted in outpatient settings.

  1. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Brain Metastases Working Group.

    Science.gov (United States)

    Lin, Nancy U; Prowell, Tatiana; Tan, Antoinette R; Kozak, Marina; Rosen, Oliver; Amiri-Kordestani, Laleh; White, Julia; Sul, Joohee; Perkins, Louise; Beal, Katherine; Gaynor, Richard; Kim, Edward S

    2017-10-02

    Purpose Broadening trial eligibility to improve accrual and access and to better reflect intended-to-treat populations has been recognized as a priority. Historically, patients with brain metastases have been understudied, because of restrictive eligibility across all phases of clinical trials. Methods In 2016, after a literature search and series of teleconferences, a multistakeholder workshop was convened. Our working group focused on developing consensus recommendations regarding the inclusion of patients with brain metastases in clinical trials, as part of a broader effort that encompassed minimum age, HIV status, and organ dysfunction. The working group attempted to balance the needs of protecting patient safety, facilitating access to investigational therapies, and ensuring trial integrity. On the basis of input at the workshop, guidelines were further refined and finalized. Results The working group identified three key populations: those with treated/stable brain metastases, defined as patients who have received prior therapy for their brain metastases and whose CNS disease is radiographically stable at study entry; those with active brain metastases, defined as new and/or progressive brain metastases at the time of study entry; and those with leptomeningeal disease. In most circumstances, the working group encourages the inclusion of patients with treated/stable brain metastases in clinical trials. A framework of key considerations for patients with active brain metastases was developed. For patients with leptomeningeal disease, inclusion of a separate cohort in both early-phase and later-phase trials is recommended, if CNS activity is anticipated and when relevant to the specific disease type. Conclusion Expanding eligibility to be more inclusive of patients with brain metastasis is justified in many cases and may speed the development of effective therapies in this area of high clinical need.

  2. Preliminary Toxicity Analysis of 3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy on the High-Dose Arm of the Radiation Therapy Oncology Group 0126 Prostate Cancer Trial

    Energy Technology Data Exchange (ETDEWEB)

    Michalski, Jeff M., E-mail: jmichalski@radonc.wustl.edu [Department of Radiation Oncology Washington University Medical Center, St. Louis, Missouri (United States); Yan, Yan [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Watkins-Bruner, Deborah [Emory University School of Nursing, Atlanta, Georgia (United States); Bosch, Walter R. [Department of Radiation Oncology Washington University Medical Center, St. Louis, Missouri (United States); Winter, Kathryn [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Bahary, Jean-Paul [Department of Radiation Oncology Centre Hospitalier de l' Université de Montréal-Notre Dame, Montreal, QC (Canada); Morton, Gerard C. [Department of Radiation Oncology Toronto-Sunnybrook Regional Cancer Centre, Toronto, ON (Canada); Parliament, Matthew B. [Department of Oncology Cross Cancer Institute, Edmonton, AB (Canada); Sandler, Howard M. [Department of Radiation Oncology Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California (United States)

    2013-12-01

    Purpose: To give a preliminary report of clinical and treatment factors associated with toxicity in men receiving high-dose radiation therapy (RT) on a phase 3 dose-escalation trial. Methods and Materials: The trial was initiated with 3-dimensional conformal RT (3D-CRT) and amended after 1 year to allow intensity modulated RT (IMRT). Patients treated with 3D-CRT received 55.8 Gy to a planning target volume that included the prostate and seminal vesicles, then 23.4 Gy to prostate only. The IMRT patients were treated to the prostate and proximal seminal vesicles to 79.2 Gy. Common Toxicity Criteria, version 2.0, and Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late morbidity scores were used for acute and late effects. Results: Of 763 patients randomized to the 79.2-Gy arm of Radiation Therapy Oncology Group 0126 protocol, 748 were eligible and evaluable: 491 and 257 were treated with 3D-CRT and IMRT, respectively. For both bladder and rectum, the volumes receiving 65, 70, and 75 Gy were significantly lower with IMRT (all P<.0001). For grade (G) 2+ acute gastrointestinal/genitourinary (GI/GU) toxicity, both univariate and multivariate analyses showed a statistically significant decrease in G2+ acute collective GI/GU toxicity for IMRT. There were no significant differences with 3D-CRT or IMRT for acute or late G2+ or 3+ GU toxicities. Univariate analysis showed a statistically significant decrease in late G2+ GI toxicity for IMRT (P=.039). On multivariate analysis, IMRT showed a 26% reduction in G2+ late GI toxicity (P=.099). Acute G2+ toxicity was associated with late G3+ toxicity (P=.005). With dose–volume histogram data in the multivariate analysis, RT modality was not significant, whereas white race (P=.001) and rectal V70 ≥15% were associated with G2+ rectal toxicity (P=.034). Conclusions: Intensity modulated RT is associated with a significant reduction in acute G2+ GI/GU toxicity. There is a trend for a

  3. WE-AB-BRA-07: Quantitative Evaluation of 2D-2D and 2D-3D Image Guided Radiation Therapy for Clinical Trial Credentialing, NRG Oncology/RTOG

    Energy Technology Data Exchange (ETDEWEB)

    Giaddui, T; Yu, J; Xiao, Y [Thomas Jefferson University, Philadelphia, PA (United States); Jacobs, P [MIM Software, Inc, Cleavland, Ohio (United States); Manfredi, D; Linnemann, N [IROC Philadelphia, RTQA Center, Philadelphia, PA (United States)

    2015-06-15

    Purpose: 2D-2D kV image guided radiation therapy (IGRT) credentialing evaluation for clinical trial qualification was historically qualitative through submitting screen captures of the fusion process. However, as quantitative DICOM 2D-2D and 2D-3D image registration tools are implemented in clinical practice for better precision, especially in centers that treat patients with protons, better IGRT credentialing techniques are needed. The aim of this work is to establish methodologies for quantitatively reviewing IGRT submissions based on DICOM 2D-2D and 2D-3D image registration and to test the methodologies in reviewing 2D-2D and 2D-3D IGRT submissions for RTOG/NRG Oncology clinical trials qualifications. Methods: DICOM 2D-2D and 2D-3D automated and manual image registration have been tested using the Harmony tool in MIM software. 2D kV orthogonal portal images are fused with the reference digital reconstructed radiographs (DRR) in the 2D-2D registration while the 2D portal images are fused with DICOM planning CT image in the 2D-3D registration. The Harmony tool allows alignment of the two images used in the registration process and also calculates the required shifts. Shifts calculated using MIM are compared with those submitted by institutions for IGRT credentialing. Reported shifts are considered to be acceptable if differences are less than 3mm. Results: Several tests have been performed on the 2D-2D and 2D-3D registration. The results indicated good agreement between submitted and calculated shifts. A workflow for reviewing these IGRT submissions has been developed and will eventually be used to review IGRT submissions. Conclusion: The IROC Philadelphia RTQA center has developed and tested a new workflow for reviewing DICOM 2D-2D and 2D-3D IGRT credentialing submissions made by different cancer clinical centers, especially proton centers. NRG Center for Innovation in Radiation Oncology (CIRO) and IROC RTQA center continue their collaborative efforts to enhance

  4. Hawaii Space Grant Consortium

    Science.gov (United States)

    Flynn, Luke P.

    2005-01-01

    The Hawai'i Space Grant Consortium is composed of ten institutions of higher learning including the University of Hawai'i at Manoa, the University of Hawai'i at Hilo, the University of Guam, and seven Community Colleges spread over the 4 main Hawaiian islands. Geographic separation is not the only obstacle that we face as a Consortium. Hawai'i has been mired in an economic downturn due to a lack of tourism for almost all of the period (2001 - 2004) covered by this report, although hotel occupancy rates and real estate sales have sky-rocketed in the last year. Our challenges have been many including providing quality educational opportunities in the face of shrinking State and Federal budgets, encouraging science and technology course instruction at the K-12 level in a public school system that is becoming less focused on high technology and more focused on developing basic reading and math skills, and assembling community college programs with instructors who are expected to teach more classes for the same salary. Motivated people can overcome these problems. Fortunately, the Hawai'i Space Grant Consortium (HSGC) consists of a group of highly motivated and talented individuals who have not only overcome these obstacles, but have excelled with the Program. We fill a critical need within the State of Hawai'i to provide our children with opportunities to pursue their dreams of becoming the next generation of NASA astronauts, engineers, and explorers. Our strength lies not only in our diligent and creative HSGC advisory board, but also with Hawai'i's teachers, students, parents, and industry executives who are willing to invest their time, effort, and resources into Hawai'i's future. Our operational philosophy is to FACE the Future, meaning that we will facilitate, administer, catalyze, and educate in order to achieve our objective of creating a highly technically capable workforce both here in Hawai'i and for NASA. In addition to administering to programs and

  5. IPD-Work consortium

    DEFF Research Database (Denmark)

    Kivimäki, Mika; Singh-Manoux, Archana; Virtanen, Marianna

    2015-01-01

    to advance research on associations between work-related psychosocial risk factors and health; (ii) demonstrate as unfounded Choi et al's assertion that IPD-Work has underestimated associations between job strain and health endpoints; these include the dichotomous measurement of job strain, potential......Established in 2008 and comprising over 60 researchers, the IPD-Work (individual-participant data meta-analysis in working populations) consortium is a collaborative research project that uses pre-defined meta-analyses of individual-participant data from multiple cohort studies representing a range......-Work's findings have also generated disagreement as they challenge the importance of job strain as a major target for coronary heart disease (CHD) prevention, this is reflected in the critical discussion paper by Choi et al (1). In this invited reply to Choi et al, we aim to (i) describe how IPD-Work seeks...

  6. The Genomic Standards Consortium.

    Directory of Open Access Journals (Sweden)

    Dawn Field

    2011-06-01

    Full Text Available A vast and rich body of information has grown up as a result of the world's enthusiasm for 'omics technologies. Finding ways to describe and make available this information that maximise its usefulness has become a major effort across the 'omics world. At the heart of this effort is the Genomic Standards Consortium (GSC, an open-membership organization that drives community-based standardization activities, Here we provide a short history of the GSC, provide an overview of its range of current activities, and make a call for the scientific community to join forces to improve the quality and quantity of contextual information about our public collections of genomes, metagenomes, and marker gene sequences.

  7. Gas Storage Technology Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Joel Morrison

    2005-09-14

    Gas storage is a critical element in the natural gas industry. Producers, transmission and distribution companies, marketers, and end users all benefit directly from the load balancing function of storage. The unbundling process has fundamentally changed the way storage is used and valued. As an unbundled service, the value of storage is being recovered at rates that reflect its value. Moreover, the marketplace has differentiated between various types of storage services, and has increasingly rewarded flexibility, safety, and reliability. The size of the natural gas market has increased and is projected to continue to increase towards 30 trillion cubic feet (TCF) over the next 10 to 15 years. Much of this increase is projected to come from electric generation, particularly peaking units. Gas storage, particularly the flexible services that are most suited to electric loads, is critical in meeting the needs of these new markets. In order to address the gas storage needs of the natural gas industry, an industry driven consortium was created--the Gas Storage Technology Consortium (GSTC). The objective of the GSTC is to provide a means to accomplish industry-driven research and development designed to enhance operational flexibility and deliverability of the Nation's gas storage system, and provide a cost effective, safe, and reliable supply of natural gas to meet domestic demand. This report addresses the activities for the quarterly period of April 1, 2005 through June 30, 2005. During this time period efforts were directed toward (1) GSTC administration changes, (2) participating in the American Gas Association Operations Conference and Biennial Exhibition, (3) issuing a Request for Proposals (RFP) for proposal solicitation for funding, and (4) organizing the proposal selection meeting.

  8. Gas Storage Technology Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Joel L. Morrison; Sharon L. Elder

    2007-06-30

    Gas storage is a critical element in the natural gas industry. Producers, transmission and distribution companies, marketers, and end users all benefit directly from the load balancing function of storage. The unbundling process has fundamentally changed the way storage is used and valued. As an unbundled service, the value of storage is being recovered at rates that reflect its value. Moreover, the marketplace has differentiated between various types of storage services and has increasingly rewarded flexibility, safety, and reliability. The size of the natural gas market has increased and is projected to continue to increase towards 30 trillion cubic feet over the next 10 to 15 years. Much of this increase is projected to come from electric generation, particularly peaking units. Gas storage, particularly the flexible services that are most suited to electric loads, is crucial in meeting the needs of these new markets. To address the gas storage needs of the natural gas industry, an industry-driven consortium was created--the Gas Storage Technology Consortium (GSTC). The objective of the GSTC is to provide a means to accomplish industry-driven research and development designed to enhance the operational flexibility and deliverability of the nation's gas storage system, and provide a cost-effective, safe, and reliable supply of natural gas to meet domestic demand. This report addresses the activities for the quarterly period of April 1, 2007 through June 30, 2007. Key activities during this time period included: (1) Organizing and hosting the 2007 GSTC Spring Meeting; (2) Identifying the 2007 GSTC projects, issuing award or declination letters, and begin drafting subcontracts; (3) 2007 project mentoring teams identified; (4) New NETL Project Manager; (5) Preliminary planning for the 2007 GSTC Fall Meeting; (6) Collecting and compiling the 2005 GSTC project final reports; and (7) Outreach and communications.

  9. Gas Storage Technology Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Joel L. Morrison; Sharon L. Elder

    2007-03-31

    Gas storage is a critical element in the natural gas industry. Producers, transmission and distribution companies, marketers, and end users all benefit directly from the load balancing function of storage. The unbundling process has fundamentally changed the way storage is used and valued. As an unbundled service, the value of storage is being recovered at rates that reflect its value. Moreover, the marketplace has differentiated between various types of storage services and has increasingly rewarded flexibility, safety, and reliability. The size of the natural gas market has increased and is projected to continue to increase towards 30 trillion cubic feet (TCF) over the next 10 to 15 years. Much of this increase is projected to come from electric generation, particularly peaking units. Gas storage, particularly the flexible services that are most suited to electric loads, is crucial in meeting the needs of these new markets. To address the gas storage needs of the natural gas industry, an industry-driven consortium was created - the Gas Storage Technology Consortium (GSTC). The objective of the GSTC is to provide a means to accomplish industry-driven research and development designed to enhance the operational flexibility and deliverability of the nation's gas storage system, and provide a cost-effective, safe, and reliable supply of natural gas to meet domestic demand. This report addresses the activities for the quarterly period of January1, 2007 through March 31, 2007. Key activities during this time period included: {lg_bullet} Drafting and distributing the 2007 RFP; {lg_bullet} Identifying and securing a meeting site for the GSTC 2007 Spring Proposal Meeting; {lg_bullet} Scheduling and participating in two (2) project mentoring conference calls; {lg_bullet} Conducting elections for four Executive Council seats; {lg_bullet} Collecting and compiling the 2005 GSTC Final Project Reports; and {lg_bullet} Outreach and communications.

  10. Gas Storage Technology Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Joel L. Morrison; Sharon L. Elder

    2006-05-10

    Gas storage is a critical element in the natural gas industry. Producers, transmission and distribution companies, marketers, and end users all benefit directly from the load balancing function of storage. The unbundling process has fundamentally changed the way storage is used and valued. As an unbundled service, the value of storage is being recovered at rates that reflect its value. Moreover, the marketplace has differentiated between various types of storage services, and has increasingly rewarded flexibility, safety, and reliability. The size of the natural gas market has increased and is projected to continue to increase towards 30 trillion cubic feet (TCF) over the next 10 to 15 years. Much of this increase is projected to come from electric generation, particularly peaking units. Gas storage, particularly the flexible services that are most suited to electric loads, is critical in meeting the needs of these new markets. In order to address the gas storage needs of the natural gas industry, an industry-driven consortium was created--the Gas Storage Technology Consortium (GSTC). The objective of the GSTC is to provide a means to accomplish industry-driven research and development designed to enhance operational flexibility and deliverability of the Nation's gas storage system, and provide a cost effective, safe, and reliable supply of natural gas to meet domestic demand. This report addresses the activities for the quarterly period of January 1, 2006 through March 31, 2006. Activities during this time period were: (1) Organize and host the 2006 Spring Meeting in San Diego, CA on February 21-22, 2006; (2) Award 8 projects for co-funding by GSTC for 2006; (3) New members recruitment; and (4) Improving communications.

  11. Nuclear Fabrication Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Levesque, Stephen [EWI, Columbus, OH (United States)

    2013-04-05

    This report summarizes the activities undertaken by EWI while under contract from the Department of Energy (DOE) Office of Nuclear Energy (NE) for the management and operation of the Nuclear Fabrication Consortium (NFC). The NFC was established by EWI to independently develop, evaluate, and deploy fabrication approaches and data that support the re-establishment of the U.S. nuclear industry: ensuring that the supply chain will be competitive on a global stage, enabling more cost-effective and reliable nuclear power in a carbon constrained environment. The NFC provided a forum for member original equipment manufactures (OEM), fabricators, manufacturers, and materials suppliers to effectively engage with each other and rebuild the capacity of this supply chain by : Identifying and removing impediments to the implementation of new construction and fabrication techniques and approaches for nuclear equipment, including system components and nuclear plants. Providing and facilitating detailed scientific-based studies on new approaches and technologies that will have positive impacts on the cost of building of nuclear plants. Analyzing and disseminating information about future nuclear fabrication technologies and how they could impact the North American and the International Nuclear Marketplace. Facilitating dialog and initiate alignment among fabricators, owners, trade associations, and government agencies. Supporting industry in helping to create a larger qualified nuclear supplier network. Acting as an unbiased technology resource to evaluate, develop, and demonstrate new manufacturing technologies. Creating welder and inspector training programs to help enable the necessary workforce for the upcoming construction work. Serving as a focal point for technology, policy, and politically interested parties to share ideas and concepts associated with fabrication across the nuclear industry. The report the objectives and summaries of the Nuclear Fabrication Consortium

  12. Oncological considerations of skin-sparing mastectomy

    OpenAIRE

    Cunnick, GH; Mokbel, K

    2006-01-01

    Aim To review evidence concerning the oncological safety of performing skin-sparing mastectomy (SSM) for invasive breast cancer and ductal carcinoma in situ (DCIS). Furthermore, the evidence concerning RT in relation to SSM and the possibility of nipple preservation was considered. Methods Literature review facilitated by Medline and PubMed databases. Findings Despite the lack of randomised controlled trials, SSM has become an accepted procedure in women undergoing mastectomy and immediate re...

  13. Gas Storage Technology Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Joel Morrison; Elizabeth Wood; Barbara Robuck

    2010-09-30

    The EMS Energy Institute at The Pennsylvania State University (Penn State) has managed the Gas Storage Technology Consortium (GSTC) since its inception in 2003. The GSTC infrastructure provided a means to accomplish industry-driven research and development designed to enhance the operational flexibility and deliverability of the nation's gas storage system, and provide a cost-effective, safe, and reliable supply of natural gas to meet domestic demand. The GSTC received base funding from the U.S. Department of Energy's (DOE) National Energy Technology Laboratory (NETL) Oil & Natural Gas Supply Program. The GSTC base funds were highly leveraged with industry funding for individual projects. Since its inception, the GSTC has engaged 67 members. The GSTC membership base was diverse, coming from 19 states, the District of Columbia, and Canada. The membership was comprised of natural gas storage field operators, service companies, industry consultants, industry trade organizations, and academia. The GSTC organized and hosted a total of 18 meetings since 2003. Of these, 8 meetings were held to review, discuss, and select proposals submitted for funding consideration. The GSTC reviewed a total of 75 proposals and committed co-funding to support 31 industry-driven projects. The GSTC committed co-funding to 41.3% of the proposals that it received and reviewed. The 31 projects had a total project value of $6,203,071 of which the GSTC committed $3,205,978 in co-funding. The committed GSTC project funding represented an average program cost share of 51.7%. Project applicants provided an average program cost share of 48.3%. In addition to the GSTC co-funding, the consortium provided the domestic natural gas storage industry with a technology transfer and outreach infrastructure. The technology transfer and outreach were conducted by having project mentoring teams and a GSTC website, and by working closely with the Pipeline Research Council International (PRCI) to

  14. The SAATELLITE and EVADE Clinical Studies Within the COMBACTE Consortium : A Public-Private Collaborative Effort in Designing and Performing Clinical Trials for Novel Antibacterial Drugs to Prevent Nosocomial Pneumonia

    NARCIS (Netherlands)

    François, Bruno; Chastre, Jean; Eggiman, Philippe; Laterre, Pierre-François; Torres, Antoni; Sanchez, Miguel; Esser, Mark T; Bishop, Brian; Bonten, Marc; Goosens, Herman; Jafri, Hasan S

    2016-01-01

    The Innovative Medicines Initiative-funded COMBACTE consortium fosters academic-industry partnership in pioneering studies to combat serious bacterial infections. We describe how this partnership is advancing the development of 2 monoclonal antibodies, MEDI4893 and MEDI3902, for the prevention of no

  15. Quality of Life (QOL) Analysis of a Randomized Radiation Dose Escalation Non-Small Cell Lung Cancer (NSCLC) Study: Radiation Therapy Oncology Group (RTOG) Trial 0617

    Science.gov (United States)

    Movsas, Benjamin; Hu, Chen; Sloan, Jeffrey; Bradley, Jeffrey; Komaki, Ritsuko; Masters, Gregory; Kavadi, Vivek; Narayan, Samir; Michalski, Jeff; Johnson, Douglas W.; Koprowski, Christopher; Curran, Walter J.; Garces, Yolanda I.; Gaur, Rakesh; Wynn, Raymond B.; Schallenkamp, John; Gelblum, Daphna Y.; MacRae, Robert M; Paulus, Rebecca; Choy, Hak

    2015-01-01

    Importance A recent randomized radiation dose escalation trial in unresectable stage III NSCLC showed a lower survival in the high-dose arm (74Gy vs. 60Gy) with concurrent chemotherapy. Quality of life (QOL), an important secondary endpoint, is presented here. Objective The primary QOL hypothesis predicted a clinically meaningful decline (CMD) in QOL via the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) in the high-dose RT-arm at 3 months. Design RTOG 0617 was a randomized phase III study (conducted from Nov 2007 to Nov 2011) in stage III NSCLC using a 2×2 factorial design and stratified by histology, PET staging, performance status and radiation technique (3D-conformal RT [3DCRT] vs. intensity-modulated radiation [IMRT]). Setting 185 institutions in the USA and Canada. Participants Of 424 eligible stage III NSCLC patients randomized, 360 (85%) consented to QOL, of whom 313 (88%) completed baseline QOL assessments. Intervention for Clinical Trials 74Gy vs. 60Gy with concurrent and consolidation carboplatin/paclitaxel +/− cetuximab. Main Outcomes and Measures QOL was collected prospectively via FACT-Trial Outcome Index (FACT-TOI), equaling Physical-Well-Being (PWB) + Functional-Well-Being (FWB) + Lung Cancer Subscale (LCS). Data are presented at baseline & 3 and 12 months via minimal clinically meaningful changes of >=2 points for PWB, FWB or LCS or >=5 points for TOI. Results Patient demographics and baseline QOL scores were comparable between the 74Gy and 60Gy arms. Two-hundred-nineteen (72%) of living patients who completed QOL at baseline did so at 3 months and 137 (57%) of living patients did so at 12 months. Significantly more patients on 74Gy arm had clinically meaningful decline in FACT-LCS at 3 months than on the 60Gy arm (45% vs. 30%, p=0.02). At 12 months, fewer patients who received IMRT (vs 3DCRT) had clinically meaningful decline in FACT-LCS (21% vs 46%, p=0.003). Baseline FACT-TOI was associated with overall survival in

  16. The International Human Epigenome Consortium

    DEFF Research Database (Denmark)

    Stunnenberg, Hendrik G; Hirst, Martin

    2016-01-01

    The International Human Epigenome Consortium (IHEC) coordinates the generation of a catalog of high-resolution reference epigenomes of major primary human cell types. The studies now presented (see the Cell Press IHEC web portal at http://www.cell.com/consortium/IHEC) highlight the coordinated ac...... achievements of IHEC teams to gather and interpret comprehensive epigenomic datasets to gain insights in the epigenetic control of cell states relevant for human health and disease. PAPERCLIP.......The International Human Epigenome Consortium (IHEC) coordinates the generation of a catalog of high-resolution reference epigenomes of major primary human cell types. The studies now presented (see the Cell Press IHEC web portal at http://www.cell.com/consortium/IHEC) highlight the coordinated...

  17. Atlantic Coast Environmental Indicators Consortium

    Data.gov (United States)

    Federal Laboratory Consortium — n 2000, the US EPA granted authority to establish up to five Estuarine Indicator Research Programs. These Programs were designed to identify, evaluate, recommend and...

  18. A phase II clinical trial of endoscopic submucosal dissection for early gastric cancer of undifferentiated type: Japan Clinical Oncology Group study JCOG1009/1010.

    Science.gov (United States)

    Takizawa, Kohei; Takashima, Atsuo; Kimura, Aya; Mizusawa, Junki; Hasuike, Noriaki; Ono, Hiroyuki; Terashima, Masanori; Muto, Manabu; Boku, Narikazu; Sasako, Mitsuru; Fukuda, Haruhiko

    2013-01-01

    A Phase II clinical trial has been initiated to evaluate the efficacy and safety of endoscopic submucosal dissection for intramucosal (cT1a) gastric cancer of undifferentiated type. Patients with cT1a gastric cancer with undifferentiated-type adenocarcinoma are eligible for the study. The tumor size should be 2 cm or less without ulceration. The study will enroll a total of 325 patients from 51 institutions over a 4-year period. The primary endpoint is proportion of 5-year overall survival (% 5-year overall survival) in patients with undifferentiated dominant type. The secondary endpoints are overall survival, relapse-free survival, distant metastasis-free survival, % 5-year overall survival without either recurrence or gastrectomy, % en-bloc resection with endoscopic submucosal dissection, % pathological curative resection with endoscopic submucosal dissection, % 5-year overall survival in patients with differentiated dominant type, % 5-year overall survival in patients with pathologically curative resection with endoscopic submucosal dissection and adverse events.

  19. Validation of Lysyl Oxidase As a Prognostic Marker for Metastasis and Survival in Head and Neck Squamous Cell Carcinoma: Radiation Therapy Oncology Group Trial 90-03

    Science.gov (United States)

    Le, Quynh-Thu; Harris, Jonathan; Magliocco, Anthony M.; Kong, Christina S.; Diaz, Roman; Shin, Brian; Cao, Hongbin; Trotti, Andy; Erler, Janine T.; Chung, Christine H.; Dicker, Adam; Pajak, Thomas F.; Giaccia, Amato J.; Ang, K. Kian

    2009-01-01

    Purpose To validate lysyl oxidase (LOX), a hypoxia-related protein, as a marker for metastasis in an independent head and neck cancer (HNC) patient group enrolled onto a prospective trial. Patients and Methods We performed traditional immunohistochemical (IHC) staining and automated quantitative analysis (AQUA) for LOX expression in 66 HNC patients from one institution. We also performed AQUA staining for LOX in 306 of 1,113 patients treated on a phase III trial comparing four radiation fractionation schedules in locally advanced HNC (RTOG 90-03). Pretreatment characteristics and outcome were similar between patients with and without LOX assessment. We correlated AQUA LOX expression with time to metastasis (TTM), time to progression (TTP), and overall survival (OS). Results LOX expression from both staining methods predicted for TTM in the first 66 patients. Multivariate analysis, controlling for significant parameters including nodal stage and performance status, revealed tumor LOX expression, as a continuous variable, was an independent predictor for TTM (hazard ratio [HR], 1.21; 95% CI, 1.10 to 1.33; P = .0001), TTP (HR, 1.06; 95% CI, 1.02 to 1.10; P = .0069), and OS (HR, 1.04; 95% CI, 1.00 to 1.07; P = .0311) in RTOG 90-03 patients. This translates into a 259% increase in metastatic risk for a patient at the 75th percentile of LOX compared with one at the 25th percentile. Conclusion AQUA LOX expression was strongly associated with increased metastasis, progression, and death in RTOG 90-03 patients. This study validates that LOX is a marker for metastasis and survival in HNC. PMID:19667273

  20. Randomized Controlled Trial of Interval-Compressed Chemotherapy for the Treatment of Localized Ewing Sarcoma: A Report From the Children's Oncology Group

    Science.gov (United States)

    Womer, Richard B.; West, Daniel C.; Krailo, Mark D.; Dickman, Paul S.; Pawel, Bruce R.; Grier, Holcombe E.; Marcus, Karen; Sailer, Scott; Healey, John H.; Dormans, John P.; Weiss, Aaron R.

    2012-01-01

    Purpose Chemotherapy with alternating vincristine-doxorubicin-cyclophosphamide and ifosfamide-etoposide cycles and primary tumor treatment with surgery and/or radiation therapy constitute the usual approach to localized Ewing sarcoma in North America. We tested whether chemotherapy intensification through interval compression could improve outcome. Patients and Methods This was a prospective, randomized controlled trial for patients younger than 50 years old with newly diagnosed localized extradural Ewing sarcoma. Patients assigned to standard and intensified treatment were to begin chemotherapy cycles every 21 and 14 days, respectively, provided an absolute neutrophil count greater than 750 × 106/L and a platelet count greater than 75 × 109/L. Patients received vincristine (2 mg/m2), doxorubicin (75 mg/m2), and cyclophosphamide (1.2 g/m2) alternating with ifosfamide (9 g/m2) and etoposide (500 mg/m2) for 14 cycles, with filgrastim (5 mg/kg per day; maximum, 300 mg) between cycles. Primary tumor treatment (surgery, radiation, or both) was to begin at week 13 (after four cycles in the standard arm and six cycles in the intensified arm). The primary end point was event-free survival (EFS). The study is registered at ClinicalTrials.gov (identifier: NCT00006734). Results Five hundred eighty-seven patients were enrolled and randomly assigned, and 568 patients were eligible, with 284 patients in each regimen. For all cycles, the median cycle interval for standard treatment was 21 days (mean, 22.45 days); for intensified treatment, the median interval was 15 days (mean, 17.29 days). EFS at a median of 5 years was 65% in the standard arm and 73% in the intensified arm (P = .048). The toxicity of the regimens was similar. Conclusion For localized Ewing sarcoma, chemotherapy administered every 2 weeks is more effective than chemotherapy administered every 3 weeks, with no increase in toxicity. PMID:23091096

  1. Body Mass Index at Diagnosis and Breast Cancer Survival Prognosis in Clinical Trial Populations from NRG Oncology/NSABP B-30, B-31, B-34, and B-38.

    Science.gov (United States)

    Cecchini, Reena S; Swain, Sandra M; Costantino, Joseph P; Rastogi, Priya; Jeong, Jong-Hyeon; Anderson, Stewart J; Tang, Gong; Geyer, Charles E; Lembersky, Barry C; Romond, Edward H; Paterson, Alexander H G; Wolmark, Norman

    2016-01-01

    Body mass index (BMI) has been associated with breast cancer outcomes. However, few studies used clinical trial settings where treatments and outcomes are consistently evaluated and documented. There are also limited data assessing how patient/disease characteristics and treatment may alter the BMI-breast cancer association. We evaluated 15,538 breast cancer participants from four NSABP protocols. B-34 studied early-stage breast cancer patients (N = 3,311); B-30 and B-38 included node-positive breast cancer patients (N = 5,265 and 4,860); and B-31 studied node-positive and HER2-positive breast cancer patients (N = 2,102). We used Cox proportional hazards regression to calculate adjusted hazards ratios (HR) for risk of death and recurrence, and conducted separate analyses by estrogen receptor (ER) status and treatment group. In B-30, increased BMI was significantly related to survival. Compared with BMI BMI 25 to 29.9 and 1.18 for BMI ≥ 30 (P = 0.02). Separate analyses indicated the significant relationship was only in ER-positive disease (P = 0.002) and the subgroup treated with doxorubicin/cyclophosphamide (P = 0.005). There were no significant trends across BMI for the other three trials. Similar results were found for recurrence. Increased BMI was significantly related to recurrence in B-30 (P = 0.03); and the significant relationship was only in ER-positive breast cancers (P = 0.001). Recurrence was also significant among ER-positive disease in B-38 (P = 0.03). In our investigation, we did not find a consistent relationship between BMI at diagnosis and breast cancer recurrence or death. This work demonstrates that the heterogeneity of breast cancer between different breast cancer populations and the different therapies used to treat them may modify any association that exists between BMI and breast cancer outcome. ©2015 American Association for Cancer Research.

  2. American Society for Radiation Oncology

    Science.gov (United States)

    ... for other cancer types View videos on radiation oncology Please Select an Action Read a news release ... This online career board is the premier radiation oncology recruitment tool, offering employers and job seekers an ...

  3. Comparative oncology today.

    Science.gov (United States)

    Paoloni, Melissa C; Khanna, Chand

    2007-11-01

    The value of comparative oncology has been increasingly recognized in the field of cancer research, including the identification of cancer-associated genes; the study of environmental risk factors, tumor biology, and progression; and, perhaps most importantly, the evaluation of novel cancer therapeutics. The fruits of this effort are expected to be the creation of better and more specific drugs to benefit veterinary and human patients who have cancer. The state of the comparative oncology field is outlined in this article, with an emphasis on cancer in dogs.

  4. Female Representation in the Academic Oncology Physician Workforce: Radiation Oncology Losing Ground to Hematology Oncology.

    Science.gov (United States)

    Ahmed, Awad A; Hwang, Wei-Ting; Holliday, Emma B; Chapman, Christina H; Jagsi, Reshma; Thomas, Charles R; Deville, Curtiland

    2017-05-01

    Our purpose was to assess comparative female representation trends for trainees and full-time faculty in the academic radiation oncology and hematology oncology workforce of the United States over 3 decades. Simple linear regression models with year as the independent variable were used to determine changes in female percentage representation per year and associated 95% confidence intervals for trainees and full-time faculty in each specialty. Peak representation was 48.4% (801/1654) in 2013 for hematology oncology trainees, 39.0% (585/1499) in 2014 for hematology oncology full-time faculty, 34.8% (202/581) in 2007 for radiation oncology trainees, and 27.7% (439/1584) in 2015 for radiation oncology full-time faculty. Representation significantly increased for trainees and full-time faculty in both specialties at approximately 1% per year for hematology oncology trainees and full-time faculty and 0.3% per year for radiation oncology trainees and full-time faculty. Compared with radiation oncology, the rates were 3.84 and 2.94 times greater for hematology oncology trainees and full-time faculty, respectively. Despite increased female trainee and full-time faculty representation over time in the academic oncology physician workforce, radiation oncology is lagging behind hematology oncology, with trainees declining in recent years in radiation oncology; this suggests a de facto ceiling in female representation. Whether such issues as delayed or insufficient exposure, inadequate mentorship, or specialty competitiveness disparately affect female representation in radiation oncology compared to hematology oncology are underexplored and require continued investigation to ensure that the future oncologic physician workforce reflects the diversity of the population it serves. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Protection of quality and innovation in radiation oncology. The prospective multicenter trial QUIRO of DEGRO: evaluation of time, attendance of medical staff, and resources during radiotherapy with tomotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Winkler, Cornelia; Duma, M.N.; Molls, M.; Kampfer, S. [Technische Universitaet Muenchen, Department of Radiotherapy and Radiooncology, Klinikum rechts der Isar, Munich (Germany); Popp, W. [Prime Networks AG, Basel (Switzerland); Sack, H. [University of Essen, Department of Radiation Oncology, Essen (Germany); Budach, V. [Charite University Medicine, Department of Radiation Oncology, Berlin (Germany)

    2014-10-15

    The technical progress in radiotherapy in recent years has been tremendous. This also implies a change of human and time resources. However, there is a lack of data on this topic. Therefore, the DEGRO initiated several studies in the QUIRO project on this subject. The present publication focuses on results for tomotherapy systems and compares them with other IMRT techniques. Over a period of several months, time allocation was documented using a standard form at two university hospitals. The required time for individual steps in the treatment planning process was recorded for all involved professional groups (physicist, technician, and physician) by themselves. The time monitoring at the treatment machines was performed by auxiliary employees (student research assistants). Evaluation of the data was performed for all recorded data as well as by tumor site. A comparison was made between the two involved institutions. A total of 1,691 records were analyzed: 148 from head and neck (H and N) tumors, 460 from prostate cancer, 136 from breast cancer, and 947 from other tumor entities. The mean value of all data from both centers for the definition of the target volumes for H and N tumors took a radiation oncology specialist 75 min, while a physicist needed for the physical treatment planning 214 min. For prostate carcinomas, the times were 60 and 147 min, respectively, and for the group of other entities 63 and 192 min, respectively. For the first radiation treatment, the occupancy time of the linear accelerator room was 31, 26, and 30 min for each entity (H and N, prostate, other entities, respectively). For routine treatments 22, 18, and 21 min were needed for the particular entities. Major differences in the time required for the individual steps were observed between the two centers. This study gives an overview of the time and personnel requirements in radiation therapy using a tomotherapy system. The most representative analysis could be done for the room occupancy

  6. A Randomized Trial (Irish Clinical Oncology Research Group 97-01) Comparing Short Versus Protracted Neoadjuvant Hormonal Therapy Before Radiotherapy for Localized Prostate Cancer.

    LENUS (Irish Health Repository)

    Armstrong, John G

    2010-08-24

    PURPOSE: To examine the long-term outcomes of a randomized trial comparing short (4 months; Arm 1) and long (8 months; Arm 2) neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. METHODS AND MATERIALS: Between 1997 and 2001, 276 patients were enrolled and the data from 261 were analyzed. The stratification risk factors were prostate-specific antigen level >20 ng\\/mL, Gleason score >\\/=7, and Stage T3 or more. The intermediate-risk stratum had one factor and the high-risk stratum had two or more. Staging was done from the bone scan and computed tomography findings. The primary endpoint was biochemical failure-free survival. RESULTS: The median follow-up was 102 months. The overall survival, biochemical failure-free survival. and prostate cancer-specific survival did not differ significantly between the two treatment arms, overall or at 5 years. The cumulative probability of overall survival at 5 years was 90% (range, 87-92%) in Arm 1 and 83% (range, 80-86%) in Arm 2. The biochemical failure-free survival rate at 5 years was 66% (range, 62-71%) in Arm 1 and 63% (range, 58-67%) in Arm 2. CONCLUSION: No statistically significant difference was found in biochemical failure-free survival between 4 months and 8 months of neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer.

  7. A Phase II Study of Intensity Modulated Radiation Therapy to the Pelvis for Postoperative Patients With Endometrial Carcinoma: Radiation Therapy Oncology Group Trial 0418

    Energy Technology Data Exchange (ETDEWEB)

    Jhingran, Anuja, E-mail: ajhingra@mdanderson.org [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Winter, Kathryn [RTOG Statistical Center, Philadelphia, Pennsylvania (United States); Portelance, Lorraine [University of Miami, Miami, Florida (United States); Miller, Brigitte [Carolinas Medical Center North East, Concord, North Carolina (United States); Salehpour, Mohammad [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gaur, Rakesh [St. Luke' s Hospital, Kansas City, Missouri (United States); Souhami, Luis [McGill University Health Centre, Montreal, Quebec (Canada); Small, William [Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illionis (United States); Berk, Lawrence [H. Lee Moffitt Cancer Center, Tampa, Florida (United States); Gaffney, David [Huntsman Cancer Hospital, Salt Lake City, Utah (United States)

    2012-09-01

    Purpose: To determine the feasibility of pelvic intensity modulated radiation therapy (IMRT) for patients with endometrial cancer in a multi-institutional setting and to determine whether this treatment is associated with fewer short-term bowel adverse events than standard radiation therapy. Methods: Patients with adenocarcinoma of the endometrium treated with pelvic radiation therapy alone were eligible. Guidelines for target definition and delineation, dose prescription, and dose-volume constraints for the targets and critical normal structures were detailed in the study protocol and a web-based atlas. Results: Fifty-eight patients were accrued by 25 institutions; 43 were eligible for analysis. Forty-two patients (98%) had an acceptable IMRT plan; 1 had an unacceptable variation from the prescribed dose to the nodal planning target volume. The proportions of cases in which doses to critical normal structures exceeded protocol criteria were as follows: bladder, 67%; rectum, 76%; bowel, 17%; and femoral heads, 33%. Twelve patients (28%) developed grade {>=}2 short-term bowel adverse events. Conclusions: Pelvic IMRT for endometrial cancer is feasible across multiple institutions with use of a detailed protocol and centralized quality assurance (QA). For future trials, contouring of vaginal and nodal tissue will need continued monitoring with good QA and better definitions will be needed for organs at risk.

  8. Prognostic significance of the S-phase fraction of light-chain-restricted cytoplasmic immunoglobulin (cIg) positive plasma cells in patients with newly diagnosed multiple myeloma enrolled on Eastern Cooperative Oncology Group treatment trial E9486.

    Science.gov (United States)

    Trendle, M C; Leong, T; Kyle, R A; Katzmann, J A; Oken, M M; Kay, N E; Van Ness, B G; Greipp, P R

    1999-08-01

    The bone marrow plasma cell labeling index (PCLI) as measured by bromodeoxyuridine uptake is a well-established independent prognostic factor for patients with newly diagnosed multiple myeloma, but the test is not easily done in most laboratories. The purpose of this study was to determine if the proliferative activity (% S-phase) as determined by two-color flow cytometry for cytoplasmic immunoglobulin (cIg) light chain and DNA content also had prognostic significance. As part of Eastern Cooperative Oncology Group clinical trial E9486, 500 patients had successful performance of the bone marrow PCLI. Of 349 patients who had flow cIg and DNA content cytometry, 210 had adequate data to reliably calculate S-phase %. Patients with low % S-phase fraction (/=2%), median survivals 4.1 vs. 2.9 years (P = 0.032). Measurement of the S-phase % by flow cytometry gives significant prognostic information in patients with newly diagnosed myeloma. However, in multivariate analysis, S-phase % did not add prognostic information when PCLI was in the model. S-phase % added prognostic information only when all cases with flow measurement of S-phase % were included, and when PCLI was excluded from the model. Discriminating a population of only cIg positive cells proved difficult in patients with a low percentage of bone marrow plasma cells. Methodology to measure S-phase % in patients with a low percent plasma cells is needed before this technique can be used for diagnosis and prognosis in myeloma. Copyright 1999 Wiley-Liss, Inc.

  9. Phase II Trial Assessing the Ability of Neoadjuvant Chemotherapy With or Without Second-Look Surgery to Eliminate Measurable Disease for Nongerminomatous Germ Cell Tumors: A Children's Oncology Group Study.

    Science.gov (United States)

    Goldman, Stewart; Bouffet, Eric; Fisher, Paul G; Allen, Jeffrey C; Robertson, Patricia L; Chuba, Paul J; Donahue, Bernadine; Kretschmar, Cynthia S; Zhou, Tianni; Buxton, Allen B; Pollack, Ian F

    2015-08-01

    This phase II trial evaluated the effect of neoadjuvant chemotherapy with or without second-look surgery before craniospinal irradiation on response rates and survival outcomes in children with newly diagnosed non-germinomatous germ cell tumors. Induction chemotherapy consisted of six cycles of carboplatin/etoposide alternating with ifosfamide/etoposide. Patients demonstrating less than complete response after induction chemotherapy were encouraged to undergo second-look surgery. Patients who did not achieve complete response or partial response after chemotherapy with or without second-look surgery proceeded to high-dose chemotherapy with thiotepa and etoposide and autologous peripheral blood stem-cell rescue before craniospinal irradiation. The study included 102 patients treated between January 2004 and July 2008. Median age was 12 years, and 76% were male; 53.9% had pineal region masses, and 23.5% had suprasellar lesions. Sixty-nine percent of patients achieved complete response or partial response with neoadjuvant chemotherapy. At 5 years, event-free survival was 84% ± 4% (SE) and overall survival was 93% ± 3%. During the median follow-up of 5.1 years, 16 patients recurred or progressed, with seven deaths after relapse. No deaths were attributed to therapy-related toxicity. Relapse occurred at the site of primary disease in 10 patients, at a distant site in three patients, or both in one patient. In two patients, progression was detected by marker increase alone. Increased serum α-fetoprotein was a negative prognostic variable. Histologic subtype and increase of beta-human chorionic gonadotropin were not significantly correlated with worse outcomes. Neoadjuvant chemotherapy with or without second-look surgery achieved high response rates contributing to excellent survival outcomes in children with newly diagnosed non-germinomatous germ cell tumors. This regimen should be included as a backbone for further studies. © 2015 by American Society of Clinical

  10. Quality Assessment in Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2012-07-01

    The movement to improve healthcare quality has led to a need for carefully designed quality indicators that accurately reflect the quality of care. Many different measures have been proposed and continue to be developed by governmental agencies and accrediting bodies. However, given the inherent differences in the delivery of care among medical specialties, the same indicators will not be valid across all of them. Specifically, oncology is a field in which it can be difficult to develop quality indicators, because the effectiveness of an oncologic intervention is often not immediately apparent, and the multidisciplinary nature of the field necessarily involves many different specialties. Existing and emerging comparative effectiveness data are helping to guide evidence-based practice, and the increasing availability of these data provides the opportunity to identify key structure and process measures that predict for quality outcomes. The increasing emphasis on quality and efficiency will continue to compel the medical profession to identify appropriate quality measures to facilitate quality improvement efforts and to guide accreditation, credentialing, and reimbursement. Given the wide-reaching implications of quality metrics, it is essential that they be developed and implemented with scientific rigor. The aims of the present report were to review the current state of quality assessment in oncology, identify existing indicators with the best evidence to support their implementation, and propose a framework for identifying and refining measures most indicative of true quality in oncologic care.

  11. Nanomedicine in veterinary oncology.

    Science.gov (United States)

    Lin, Tzu-Yin; Rodriguez, Carlos O; Li, Yuanpei

    2015-08-01

    Nanomedicine is an interdisciplinary field that combines medicine, engineering, chemistry, biology and material sciences to improve disease management and can be especially valuable in oncology. Nanoparticle-based agents that possess functions such as tumor targeting, imaging and therapy are currently under intensive investigation. This review introduces the basic concept of nanomedicine and the classification of nanoparticles. Because of their favorable pharmacokinetics, tumor targeting properties, and resulting superior efficacy and toxicity profiles, nanoparticle-based agents can overcome several limitations associated with conventional diagnostic and therapeutic protocols in veterinary oncology. The two most important tumor targeting mechanisms (passive and active tumor targeting) and their dominating factors (i.e. shape, charge, size and nanoparticle surface display) are discussed. The review summarizes published clinical and preclinical studies that utilize different nanoformulations in veterinary oncology, as well as the application of nanoparticles for cancer diagnosis and imaging. The toxicology of various nanoformulations is also considered. Given the benefits of nanoformulations demonstrated in human medicine, nanoformulated drugs are likely to gain more traction in veterinary oncology.

  12. Risk factors for GI adverse events in a phase III randomized trial of bevacizumab in first-line therapy of advanced ovarian cancer: A Gynecologic Oncology Group Study.

    Science.gov (United States)

    Burger, Robert A; Brady, Mark F; Bookman, Michael A; Monk, Bradley J; Walker, Joan L; Homesley, Howard D; Fowler, Jeffrey; Greer, Benjamin E; Boente, Matthew; Fleming, Gini F; Lim, Peter C; Rubin, Stephen C; Katsumata, Noriyuki; Liang, Sharon X

    2014-04-20

    To evaluate risk factors for GI adverse events (AEs) within a phase III trial of bevacizumab in first-line ovarian cancer therapy. Women with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles (C)2 to C22 (R1); chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 (R2); or chemotherapy plus bevacizumab C2 to C22 (R3). Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade ≥ 2 perforation, fistula, necrosis, or hemorrhage. Of 1,873 patients enrolled, 1,759 (94%) were evaluable, and 2.8% (50 of 1,759) experienced a GI AE: 10 of 587 (1.7%, R1), 20 of 587 (3.4%, R2), and 20 of 585 (3.4%, R3). Univariable analyses indicated that previous treatment of inflammatory bowel disease (IBD; P = .005) and small bowel resection (SBR; P = .032) or large bowel resection (LBR; P = .012) at primary surgery were significantly associated with a GI AE. The multivariable estimated relative odds of a GI AE were 13.4 (95% CI, 3.44 to 52.3; P GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer. After accounting for these risk factors, concurrent bevacizumab doubles the odds of a GI AE, but is not appreciably increased by continuation beyond chemotherapy.

  13. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte Oncology Network

    Directory of Open Access Journals (Sweden)

    Ciuffreda Libero

    2009-11-01

    Full Text Available Abstract Background Well-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU infusion plus long-acting release (LAR octreotide in patients with neuroendocrine carcinoma. Methods Twenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m2 daily plus LAR octreotide (20 mg monthly. Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival. Results Assessment by Response Evaluation Criteria in Solid Tumors (RECIST criteria showed partial response in 7 (24.1%, stable disease in 20 (69.0%, and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A response was observed in 12/25 assessable patients (48.0%; symptom relief was obtained in 9/15 symptomatic patients (60.0%. There was non significant decrease in circulating vascular epithelial growth factor (VEGF over time. Median time to progression was 22.6 months (range, 2.7-68.5; median overall survival was not reached yet. Toxicity was mild and manageable. Conclusion Continuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future. Trial registration NCT00953394

  14. Rituximab Extended Schedule or Re-Treatment Trial for Low–Tumor Burden Follicular Lymphoma: Eastern Cooperative Oncology Group Protocol E4402

    Science.gov (United States)

    Kahl, Brad S.; Hong, Fangxin; Williams, Michael E.; Gascoyne, Randy D.; Wagner, Lynne I.; Krauss, John C.; Habermann, Thomas M.; Swinnen, Lode J.; Schuster, Stephen J.; Peterson, Christopher G.; Sborov, Mark D.; Martin, S. Eric; Weiss, Matthias; Ehmann, W. Christopher; Horning, Sandra J.

    2014-01-01

    Purpose In low–tumor burden follicular lymphoma (FL), maintenance rituximab (MR) has been shown to improve progression-free survival when compared with observation. It is not known whether MR provides superior long-term disease control compared with re-treatment rituximab (RR) administered on an as-needed basis. E4402 (RESORT) was a randomized clinical trial designed to compare MR against RR. Patients and Methods Eligible patients with previously untreated low–tumor burden FL received four doses of rituximab, and responding patients were randomly assigned to either RR or MR. Patients receiving RR were eligible for re-treatment at each disease progression until treatment failure. Patients assigned to MR received a single dose of rituximab every 3 months until treatment failure. The primary end point was time to treatment failure. Secondary end points included time to first cytotoxic therapy, toxicity, and health-related quality of life (HRQOL). Results A total of 289 patients were randomly assigned to RR or MR. With a median follow-up of 4.5 years, the estimated median time to treatment failure was 3.9 years for patients receiving RR and 4.3 years for those receiving MR (P = .54). Three-year freedom from cytotoxic therapy was 84% for those receiving RR and 95% for those receiving MR (P = .03). The median number of rituximab doses was four patients receiving RR and 18 for those receiving MR. There was no difference in HRQOL. Grade 3 to 4 toxicities were infrequent in both arms. Conclusion In low–tumor burden FL, a re-treatment strategy uses less rituximab while providing disease control comparable to that achieved with a maintenance strategy. PMID:25154829

  15. Molecular imaging in oncology

    Energy Technology Data Exchange (ETDEWEB)

    Schober, Otmar; Riemann, Burkhard (eds.) [Universitaetsklinikum Muenster (Germany). Klinik fuer Nuklearmedizin

    2013-02-01

    Considers in detail all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. Examines technological issues and probe design. Discusses preclinical studies in detail, with particular attention to multimodality imaging. Presents current clinical use of PET/CT, SPECT/CT, and optical imagingWritten by acknowledged experts. The impact of molecular imaging on diagnostics, therapy, and follow-up in oncology is increasing significantly. The process of molecular imaging includes key biotarget identification, design of specific molecular imaging probes, and their preclinical evaluation, e.g., in vivo using small animal studies. A multitude of such innovative molecular imaging probes have already entered clinical diagnostics in oncology. There is no doubt that in future the emphasis will be on multimodality imaging in which morphological, functional, and molecular imaging techniques are combined in a single clinical investigation that will optimize diagnostic processes. This handbook addresses all aspects of molecular imaging in oncology, ranging from basic research to clinical applications in the era of evidence-based medicine. The first section is devoted to technology and probe design, and examines a variety of PET and SPECT tracers as well as multimodality probes. Preclinical studies are then discussed in detail, with particular attention to multimodality imaging. In the third section, diverse clinical applications are presented, and the book closes by looking at future challenges. This handbook will be of value to all who are interested in the revolution in diagnostic oncology that is being brought about by molecular imaging.

  16. ENT COBRA (Consortium for Brachytherapy Data Analysis): interdisciplinary standardized data collection system for head and neck patients treated with interventional radiotherapy (brachytherapy)

    OpenAIRE

    2016-01-01

    Purpose Aim of the COBRA (Consortium for Brachytherapy Data Analysis) project is to create a multicenter group (consortium) and a web-based system for standardized data collection. Material and methods GEC-ESTRO (Groupe Européen de Curiethérapie – European Society for Radiotherapy & Oncology) Head and Neck (H&N) Working Group participated in the project and in the implementation of the consortium agreement, the ontology (data-set) and the necessary COBRA software services as well as the peer ...

  17. The ocean sampling day consortium

    DEFF Research Database (Denmark)

    Kopf, Anna; Bicak, Mesude; Kottmann, Renzo

    2015-01-01

    Ocean Sampling Day was initiated by the EU-funded Micro B3 (Marine Microbial Biodiversity, Bioinformatics, Biotechnology) project to obtain a snapshot of the marine microbial biodiversity and function of the world’s oceans. It is a simultaneous global mega-sequencing campaign aiming to generate...... the largest standardized microbial data set in a single day. This will be achievable only through the coordinated efforts of an Ocean Sampling Day Consortium, supportive partnerships and networks between sites. This commentary outlines the establishment, function and aims of the Consortium and describes our...

  18. Combustion Byproducts Recycling Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Paul Ziemkiewicz; Tamara Vandivort; Debra Pflughoeft-Hassett; Y. Paul Chugh; James Hower

    2008-08-31

    The Combustion Byproducts Recycling Consortium (CBRC) program was developed as a focused program to remove and/or minimize the barriers for effective management of over 123 million tons of coal combustion byproducts (CCBs) annually generated in the USA. At the time of launching the CBRC in 1998, about 25% of CCBs were beneficially utilized while the remaining was disposed in on-site or off-site landfills. During the ten (10) year tenure of CBRC (1998-2008), after a critical review, 52 projects were funded nationwide. By region, the East, Midwest, and West had 21, 18, and 13 projects funded, respectively. Almost all projects were cooperative projects involving industry, government, and academia. The CBRC projects, to a large extent, successfully addressed the problems of large-scale utilization of CCBs. A few projects, such as the two Eastern Region projects that addressed the use of fly ash in foundry applications, might be thought of as a somewhat smaller application in comparison to construction and agricultural uses, but as a novel niche use, they set the stage to draw interest that fly ash substitution for Portland cement might not attract. With consideration of the large increase in flue gas desulfurization (FGD) gypsum in response to EPA regulations, agricultural uses of FGD gypsum hold promise for large-scale uses of a product currently directed to the (currently stagnant) home construction market. Outstanding achievements of the program are: (1) The CBRC successfully enhanced professional expertise in the area of CCBs throughout the nation. The enhanced capacity continues to provide technology and information transfer expertise to industry and regulatory agencies. (2) Several technologies were developed that can be used immediately. These include: (a) Use of CCBs for road base and sub-base applications; (b) full-depth, in situ stabilization of gravel roads or highway/pavement construction recycled materials; and (c) fired bricks containing up to 30%-40% F

  19. The Statewide Energy Consortium: A California Concept.

    Science.gov (United States)

    Turner, G. Cleve; Giacosie, Robert V.

    1981-01-01

    Describes the formation and organization of a statewide energy consortium consisting of faculty from 19 campuses of the California State University and Colleges system. Also describes three major consortium activities and reasons for its success. (SK)

  20. The Statewide Energy Consortium: A California Concept.

    Science.gov (United States)

    Turner, G. Cleve; Giacosie, Robert V.

    1981-01-01

    Describes the formation and organization of a statewide energy consortium consisting of faculty from 19 campuses of the California State University and Colleges system. Also describes three major consortium activities and reasons for its success. (SK)

  1. Rationale and design of the Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research Trial (MANTICORE 101 - Breast: a randomized, placebo-controlled trial to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer using cardiac MRI

    Directory of Open Access Journals (Sweden)

    Ezekowitz Justin

    2011-07-01

    Full Text Available Abstract Background MANTICORE 101 - Breast (Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research is a randomized trial to determine if conventional heart failure pharmacotherapy (angiotensin converting enzyme inhibitor or beta-blocker can prevent trastuzumab-mediated left ventricular remodeling, measured with cardiac MRI, among patients with HER2+ early breast cancer. Methods/Design One hundred and fifty-nine patients with histologically confirmed HER2+ breast cancer will be enrolled in a parallel 3-arm, randomized, placebo controlled, double-blind design. After baseline assessments, participants will be randomized in a 1:1:1 ratio to an angiotensin-converting enzyme inhibitor (perindopril, beta-blocker (bisoprolol, or placebo. Participants will receive drug or placebo for 1 year beginning 7 days before trastuzumab therapy. Dosages for all groups will be systematically up-titrated, as tolerated, at 1 week intervals for a total of 3 weeks. The primary objective of this randomized clinical trial is to determine if conventional heart failure pharmacotherapy can prevent trastuzumab-mediated left ventricular remodeling among patients with HER2+ early breast cancer, as measured by 12 month change in left ventricular end-diastolic volume using cardiac MRI. Secondary objectives include 1 determine the evolution of left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer, 2 understand the mechanism of trastuzumab mediated cardiac toxicity by assessing for the presence of myocardial injury and apoptosis on serum biomarkers and cardiac MRI, and 3 correlate cardiac biomarkers of myocyte injury and extra-cellular matrix remodeling with left ventricular remodeling on cardiac MRI in patients with HER2+ early breast cancer. Discussion Cardiac toxicity as a result of cancer therapies is now recognized as a significant health problem of increasing prevalence. To our knowledge, MANTICORE will be the first

  2. Integrative oncology: an overview.

    Science.gov (United States)

    Deng, Gary; Cassileth, Barrie

    2014-01-01

    Integrative oncology, the diagnosis-specific field of integrative medicine, addresses symptom control with nonpharmacologic therapies. Known commonly as "complementary therapies" these are evidence-based adjuncts to mainstream care that effectively control physical and emotional symptoms, enhance physical and emotional strength, and provide patients with skills enabling them to help themselves throughout and following mainstream cancer treatment. Integrative or complementary therapies are rational and noninvasive. They have been subjected to study to determine their value, to document the problems they ameliorate, and to define the circumstances under which such therapies are beneficial. Conversely, "alternative" therapies typically are promoted literally as such; as actual antitumor treatments. They lack biologic plausibility and scientific evidence of safety and efficacy. Many are outright fraudulent. Conflating these two very different categories by use of the convenient acronym "CAM," for "complementary and alternative therapies," confuses the issue and does a substantial disservice to patients and medical professionals. Complementary and integrative modalities have demonstrated safety value and benefits. If the same were true for "alternatives," they would not be "alternatives." Rather, they would become part of mainstream cancer care. This manuscript explores the medical and sociocultural context of interest in integrative oncology as well as in "alternative" therapies, reviews commonly-asked patient questions, summarizes research results in both categories, and offers recommendations to help guide patients and family members through what is often a difficult maze. Combining complementary therapies with mainstream oncology care to address patients' physical, psychologic and spiritual needs constitutes the practice of integrative oncology. By recommending nonpharmacologic modalities that reduce symptom burden and improve quality of life, physicians also enable

  3. Neurologic complications in oncology

    Directory of Open Access Journals (Sweden)

    Andrea Pace

    2010-06-01

    Full Text Available Neurologic side effects related to cancer therapy are a common problem in oncology practice. These complications can negatively affect the management of the patient, because they can inhibit treatment and diminish quality of life. Therefore specific skills are required to recognise symptoms and clinical manifestations. This review focuses on the most common neurologic complications to improve physician’s familiarity in determining the aetiology of these symptoms.

  4. Brain Tumor Epidemiology Consortium (BTEC)

    Science.gov (United States)

    The Brain Tumor Epidemiology Consortium is an open scientific forum organized to foster the development of multi-center, international and inter-disciplinary collaborations that will lead to a better understanding of the etiology, outcomes, and prevention of brain tumors.

  5. Quality Indicators in Radiation Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2013-03-15

    Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts.

  6. NCI Community Oncology Research Program (NCORP) | Division of Cancer Prevention

    Science.gov (United States)

    The NCI Community Oncology Research Program (NCORP) is a national network of cancer care investigators, providers, academia, and other organizations that care for diverse populations in health systems. View the list of publications from NCORP. | Clinical Trials network of cancer care professionals who care for diverse populations across the U.S.

  7. NCI Community Oncology Research Program Approved | Division of Cancer Prevention

    Science.gov (United States)

    On June 24, 2013, the National Cancer Institute (NCI) Board of Scientific Advisors approved the creation of the NCI Community Oncology Research Program (NCORP). NCORP will bring state-of-the art cancer prevention, control, treatment and imaging clinical trials, cancer care delivery research, and disparities studies to individuals in their own communities. |

  8. A framework for prescription in exercise-oncology research

    DEFF Research Database (Denmark)

    Sasso, John P; Eves, Neil D; Christensen, Jesper F;

    2015-01-01

    of exercise treatment in the oncology setting. Against this background, this opinion paper provides an overview of the fundamental tenets of human exercise physiology known as the principles of training, with specific application of these principles in the design and conduct of clinical trials in exercise...

  9. Decline in Tested and Self-Reported Cognitive Functioning After Prophylactic Cranial Irradiation for Lung Cancer: Pooled Secondary Analysis of Radiation Therapy Oncology Group Randomized Trials 0212 and 0214

    Energy Technology Data Exchange (ETDEWEB)

    Gondi, Vinai, E-mail: vgondi@chicagocancer.org [Central Dupage Hospital Cancer Center, Warrenville, Illinois (United States); University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin (United States); Paulus, Rebecca [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Bruner, Deborah W. [Nell Hodgson Woodfull School of Nursing, Emory University, Atlanta, Georgia (United States); Meyers, Christina A. [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Gore, Elizabeth M. [Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Wolfson, Aaron [University of Miami School of Medicine, Miami, Florida (United States); Werner-Wasik, Maria [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Sun, Alexander Y. [Princess Margaret Hospital, Toronto, ON (Canada); Choy, Hak [University of Texas Southwestern Moncreif Cancer Center, Fort Worth, Texas (United States); Movsas, Benjamin [Henry Ford Health System, Detroit, Michigan (United States)

    2013-07-15

    Purpose: To assess the impact of prophylactic cranial irradiation (PCI) on self-reported cognitive functioning (SRCF), a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0214 randomized patients with locally advanced non-small cell lung cancer to PCI or observation; RTOG 0212 randomized patients with limited-disease small cell lung cancer to high- or standard-dose PCI. In both trials, Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline (after locoregional therapy but before PCI or observation) and at 6 and 12 months. Patients developing brain relapse before follow-up evaluation were excluded. Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling. Fisher's exact test correlated decline in SRCF with HVLT decline. Results: Of the eligible patients pooled from RTOG 0212 and RTOG 0214, 410 (93%) receiving PCI and 173 (96%) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis. Prophylactic cranial irradiation was associated with a higher risk of decline in SRCF at 6 months (odds ratio 3.60, 95% confidence interval 2.34-6.37, P<.0001) and 12 months (odds ratio 3.44, 95% confidence interval 1.84-6.44, P<.0001). Decline on HVLT-Recall at 6 and 12 months was also associated with PCI (P=.002 and P=.002, respectively) but was not closely correlated with decline in SRCF at the same time points (P=.05 and P=.86, respectively). Conclusions: In lung cancer patients who do not develop brain relapse, PCI is associated with decline in HVLT-tested and self-reported cognitive functioning. Decline in HVLT and decline in SRCF are not closely correlated, suggesting that they may represent distinct elements of the cognitive spectrum.

  10. Randomized Trial Comparing Conventional-Dose With High-Dose Conformal Radiation Therapy in Early-Stage Adenocarcinoma of the Prostate: Long-Term Results From Proton Radiation Oncology Group/American College of Radiology 95-09

    Science.gov (United States)

    Zietman, Anthony L.; Bae, Kyounghwa; Slater, Jerry D.; Shipley, William U.; Efstathiou, Jason A.; Coen, John J.; Bush, David A.; Lunt, Margie; Spiegel, Daphna Y.; Skowronski, Rafi; Jabola, B. Rodney; Rossi, Carl J.

    2010-01-01

    Purpose To test the hypothesis that increasing radiation dose delivered to men with early-stage prostate cancer improves clinical outcomes. Patients and Methods Men with T1b-T2b prostate cancer and prostate-specific antigen ≤ 15 ng/mL were randomly assigned to a total dose of either 70.2 Gray equivalents (GyE; conventional) or 79.2 GyE (high). No patient received androgen suppression therapy with radiation. Local failure (LF), biochemical failure (BF), and overall survival (OS) were outcomes. Results A total of 393 men were randomly assigned, and median follow-up was 8.9 years. Men receiving high-dose radiation therapy were significantly less likely to have LF, with a hazard ratio of 0.57. The 10-year American Society for Therapeutic Radiology and Oncology BF rates were 32.4% for conventional-dose and 16.7% for high-dose radiation therapy (P < .0001). This difference held when only those with low-risk disease (n = 227; 58% of total) were examined: 28.2% for conventional and 7.1% for high dose (P < .0001). There was a strong trend in the same direction for the intermediate-risk patients (n = 144; 37% of total; 42.1% v 30.4%, P = .06). Eleven percent of patients subsequently required androgen deprivation for recurrence after conventional dose compared with 6% after high dose (P = .047). There remains no difference in OS rates between the treatment arms (78.4% v 83.4%; P = .41). Two percent of patients in both arms experienced late grade ≥ 3 genitourinary toxicity, and 1% of patients in the high-dose arm experienced late grade ≥ 3 GI toxicity. Conclusion This randomized controlled trial shows superior long-term cancer control for men with localized prostate cancer receiving high-dose versus conventional-dose radiation. This was achieved without an increase in grade ≥ 3 late urinary or rectal morbidity. PMID:20124169

  11. Corn in consortium with forages

    Directory of Open Access Journals (Sweden)

    Cássia Maria de Paula Garcia

    2013-12-01

    Full Text Available The basic premises for sustainable agricultural development with focus on rural producers are reducing the costs of production and aggregation of values through the use crop-livestock system (CLS throughout the year. The CLS is based on the consortium of grain crops, especially corn with tropical forages, mainly of the genus Panicum and Urochloa. The study aimed to evaluate the grain yield of irrigated corn crop intercropped with forage of the genus Panicum and Urochloa. The experiment was conducted at the Fazenda de Ensino, Pesquisa e Extensão – FEPE  of the Faculdade de Engenharia - UNESP, Ilha Solteira in an Oxisol in savannah conditions and in the autumn winter of 2009. The experimental area was irrigated by a center pivot and had a history of no-tillage system for 8 years. The corn hybrid used was simple DKB 390 YG at distances of 0.90 m. The seeds of grasses were sown in 0.34 m spacing in the amount of 5 kg ha-1, they were mixed with fertilizer minutes before sowing  and placed in a compartment fertilizer seeder and fertilizers were mechanically deposited in the soil at a depth of 0.03 m. The experimental design used was a randomized block with four replications and five treatments: Panicum maximum cv. Tanzania sown during the nitrogen fertilization (CTD of the corn; Panicum maximum cv. Mombaça sown during the nitrogen fertilization (CMD of the corn; Urochloa brizantha cv. Xaraés sown during the occasion of nitrogen fertilization (CBD of the corn; Urochloa ruziziensis cv. Comumsown during the nitrogen fertilization (CRD of the corn and single corn (control. The production components of corn: plant population per hectare (PlPo, number of ears per hectare (NE ha-1, number of rows per ear (NRE, number of kernels per row on the cob (NKR, number of grain in the ear (NGE and mass of 100 grains (M100G were not influenced by consortium with forage. Comparing grain yield (GY single corn and maize intercropped with forage of the genus Panicum

  12. Medicinal cannabis in oncology.

    Science.gov (United States)

    Engels, Frederike K; de Jong, Floris A; Mathijssen, Ron H J; Erkens, Joëlle A; Herings, Ron M; Verweij, Jaap

    2007-12-01

    In The Netherlands, since September 2003, a legal medicinal cannabis product, constituting the whole range of cannabinoids, is available for clinical research, drug development strategies, and on prescription for patients. To date, this policy, initiated by the Dutch Government, has not yet led to the desired outcome; the amount of initiated clinical research is less than expected and only a minority of patients resorts to the legal product. This review aims to discuss the background for the introduction of legal medicinal cannabis in The Netherlands, the past years of Dutch clinical experience in oncology practice, possible reasons underlying the current outcome, and future perspectives.

  13. The AGTSR consortium: An update

    Energy Technology Data Exchange (ETDEWEB)

    Fant, D.B.; Golan, L.P. [Clemson Univ., SC (United States)

    1995-10-01

    The Advanced Gas Turbine Systems Research (AGTSR) program is a collaborative University-Industry R&D Consortium that is managed and administered by the South Carolina Energy R&D Center. AGTSR is a nationwide consortium dedicated to advancing land-based gas turbine systems for improving future power generation capability. It directly supports the technology-research arm of the ATS program and targets industry-defined research needs in the areas of combustion, heat transfer, materials, aerodynamics, controls, alternative fuels, and advanced cycles. The consortium is organized to enhance U.S. competitiveness through close collaboration with universities, government, and industry at the R&D level. AGTSR is just finishing its third year of operation and is sponsored by the U.S. DOE - Morgantown Energy Technology Center. The program is scheduled to continue past the year 2000. At present, there are 78 performing member universities representing 36 states, and six cost-sharing U.S. gas turbine corporations. Three RFP`s have been announced and the fourth RFP is expected to be released in December, 1995. There are 31 research subcontracts underway at performing member universities. AGTSR has also organized three workshops, two in combustion and one in heat transfer. A materials workshop is in planning and is scheduled for February, 1996. An industrial internship program was initiated this past summer, with one intern positioned at each of the sponsoring companies. The AGTSR consortium nurtures close industry-university-government collaboration to enhance synergism and the transition of research results, accelerate and promote evolutionary-revolutionary R&D, and strives to keep a prominent U.S. industry strong and on top well into the 21st century. This paper will present the objectives and benefits of the AGTSR program, progress achieved to date, and future planned activity in fiscal year 1996.

  14. John Glenn Biomedical Engineering Consortium

    Science.gov (United States)

    Nall, Marsha

    2004-01-01

    The John Glenn Biomedical Engineering Consortium is an inter-institutional research and technology development, beginning with ten projects in FY02 that are aimed at applying GRC expertise in fluid physics and sensor development with local biomedical expertise to mitigate the risks of space flight on the health, safety, and performance of astronauts. It is anticipated that several new technologies will be developed that are applicable to both medical needs in space and on earth.

  15. Appalachian clean coal technology consortium

    Energy Technology Data Exchange (ETDEWEB)

    Kutz, K.; Yoon, Roe-Hoan [Virginia Polytechnic Institute and State Univ., Blacksburg, VA (United States)

    1995-11-01

    The Appalachian Clean Coal Technology Consortium (ACCTC) has been established to help U.S. coal producers, particularly those in the Appalachian region, increase the production of lower-sulfur coal. The cooperative research conducted as part of the consortium activities will help utilities meet the emissions standards established by the 1990 Clean Air Act Amendments, enhance the competitiveness of U.S. coals in the world market, create jobs in economically-depressed coal producing regions, and reduce U.S. dependence on foreign energy supplies. The research activities will be conducted in cooperation with coal companies, equipment manufacturers, and A&E firms working in the Appalachian coal fields. This approach is consistent with President Clinton`s initiative in establishing Regional Technology Alliances to meet regional needs through technology development in cooperation with industry. The consortium activities are complementary to the High-Efficiency Preparation program of the Pittsburgh Energy Technology Center, but are broader in scope as they are inclusive of technology developments for both near-term and long-term applications, technology transfer, and training a highly-skilled work force.

  16. Oncology in Cambodia.

    Science.gov (United States)

    Eav, S; Schraub, S; Dufour, P; Taisant, D; Ra, C; Bunda, P

    2012-01-01

    Cambodia, a country of 14 million inhabitants, was devastated during the Khmer Rouge period and thereafter. The resources of treatment are rare: only one radiotherapy department, renovated in 2003, with an old cobalt machine; few surgeons trained to operate on cancer patients; no hematology; no facilities to use intensive chemotherapy; no nuclear medicine department and no palliative care unit. Cervical cancer incidence is one of the highest in the world, while in men liver cancer ranks first (20% of all male cancers). Cancers are seen at stage 3 or 4 for 70% of patients. There is no prevention program - only a vaccination program against hepatitis B for newborns - and no screening program for cervical cancer or breast cancer. In 2010, oncology, recognized as a full specialty, was created to train the future oncologists on site at the University of Phnom Penh. A new National Cancer Center will be built in 2013 with modern facilities for radiotherapy, medical oncology, hematology and nuclear medicine. Cooperation with foreign countries, especially France, and international organizations has been established and is ongoing. Progress is occurring slowly due to the shortage of money for Cambodian institutions and the lay public.

  17. Molecular radio-oncology

    Energy Technology Data Exchange (ETDEWEB)

    Baumann, Michael; Krause, Mechthild; Cordes, Nils (eds.) [Technische Univ. Dresden (Germany). Faculty of Medicine and University Hospital

    2016-07-01

    This book concisely reviews our current understanding of hypoxia, molecular targeting, DNA repair, cancer stem cells, and tumor pathophysiology, while also discussing novel strategies for putting these findings into practice in daily clinical routine. Radiotherapy is an important part of modern multimodal cancer treatment, and the past several years have witnessed not only substantial improvements in radiation techniques and the use of new beam qualities, but also major strides in our understanding of molecular tumor biology and tumor radiation response. Against this backdrop, the book highlights recent efforts to identify reasonable and clinically applicable biomarkers using broad-spectrum tissue microarrays and high-throughput systems biology approaches like genomics and epigenomics. In particular, it describes in detail how such molecular information is now being exploited for diagnostic imaging and imaging throughout treatment using the example of positron emission tomography. By discussing all these issues in the context of modern radiation oncology, the book provides a broad, up-to-date overview of the molecular aspects of radiation oncology that will hopefully foster its further optimization.

  18. [Artificial intelligence applied to radiation oncology].

    Science.gov (United States)

    Bibault, J-E; Burgun, A; Giraud, P

    2017-05-01

    Performing randomised comparative clinical trials in radiation oncology remains a challenge when new treatment modalities become available. One of the most recent examples is the lack of phase III trials demonstrating the superiority of intensity-modulated radiation therapy in most of its current indications. A new paradigm is developing that consists in the mining of large databases to answer clinical or translational issues. Beyond national databases (such as SEER or NCDB), that often lack the necessary level of details on the population studied or the treatments performed, electronic health records can be used to create detailed phenotypic profiles of any patients. In parallel, the Record-and-Verify Systems used in radiation oncology precisely document the planned and performed treatments. Artificial Intelligence and machine learning algorithms can be used to incrementally analyse these data in order to generate hypothesis to better personalize treatments. This review discusses how these methods have already been used in previous studies. Copyright © 2017 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

  19. Applications of coxsackievirus A21 in oncology

    Directory of Open Access Journals (Sweden)

    Bradley S

    2014-04-01

    Full Text Available Stephen Bradley,1 Adam D Jakes,1 Kevin Harrington,2 Hardev Pandha,3 Alan Melcher,1 Fiona Errington-Mais11Leeds Institute of Cancer and Pathology, Cancer Research UK and Experimental Cancer Medicine Centre, St James' University Hospital, Leeds, UK; 2Division of Cancer Biology, The Institute of Cancer Research, London, UK; 3Oncology Department, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UKAbstract: The clinical management of cancer continues to be dominated by macroscopic surgical resection, radiotherapy, and cytotoxic drugs. The major challenge facing oncology is to achieve more selective, less toxic and effective methods of targeting disseminated tumors, a challenge oncolytic virotherapy may be well-placed to meet. Characterization of coxsackievirus A21 (CVA21 receptor-based mechanism of virus internalization and lysis in the last decade has suggested promise for CVA21 as a virotherapy against malignancies which overexpress those receptors. Preclinical studies have demonstrated proof of principle, and with the results of early clinical trials awaited, CVA21 may be one of the few viruses to demonstrate benefit for patients. This review outlines the potential of CVA21 as an oncolytic agent, describing the therapeutic development of CVA21 in preclinical studies and early stage clinical trials. Preclinical evidence supports the potential use of CVA21 across a range of malignancies. Malignant melanoma is the most intensively studied cancer, and may represent a “test case” for future development of the virus. Although there are theoretical barriers to the clinical utility of oncolytic viruses like CVA21, whether these will block the efficacy of the virus in clinical practice remains to be established, and is a question which can only be answered by appropriate trials. As these data become available, the rapid journey of CVA21 from animal studies to clinical trials may offer a model for the translation of other

  20. Perceived roles of oncology nursing.

    Science.gov (United States)

    Lemonde, Manon; Payman, Naghmeh

    2015-01-01

    The Canadian Association of Nurses in Oncology (CANO) Standards of Care (2001) provides a framework that delineates oncology nursing roles and responsibilities. The purpose of this study was to explore how oncology nurses perceive their roles and responsibilities compared to the CANO Standards of Care. Six focus groups were conducted and 21 registered nurses (RNs) from a community-based hospital participated in this study. Transcripts were analyzed using qualitative inductive content analysis. Three themes were identified: (1) Oncology nurses perceive a gap between their defined roles and the reality of daily practice, as cancer care becomes more complex and as they provide advanced oncology care to more patients while there is no parallel adaptation to the health care system to support them, such as safe staffing; (2) Oncology nursing, as a specialty, requires sustained professional development and leadership roles; and (3) Oncology nurses are committed to providing continuous care as a reference point in the health care team by fostering interdisciplinary collaboration andfacilitating patient's navigation through the system. Organizational support through commitment to appropriate staffing and matching scope ofpractice to patient needs may lead to maximize the health and well-being of nurses, quality of patient care and organizational performance.

  1. Mathematical oncology 2013

    CERN Document Server

    Gandolfi, Alberto

    2014-01-01

    With chapters on free boundaries, constitutive equations, stochastic dynamics, nonlinear diffusion–consumption, structured populations, and applications of optimal control theory, this volume presents the most significant recent results in the field of mathematical oncology. It highlights the work of world-class research teams, and explores how different researchers approach the same problem in various ways. Tumors are complex entities that present numerous challenges to the mathematical modeler. First and foremost, they grow. Thus their spatial mean field description involves a free boundary problem. Second, their interiors should be modeled as nontrivial porous media using constitutive equations. Third, at the end of anti-cancer therapy, a small number of malignant cells remain, making the post-treatment dynamics inherently stochastic. Fourth, the growth parameters of macroscopic tumors are non-constant, as are the parameters of anti-tumor therapies. Changes in these parameters may induce phenomena that a...

  2. [Dermato-oncological rehabilitation].

    Science.gov (United States)

    Buhles, N; Sander, C

    2005-07-01

    National insurance companies in Germany support health cures for patients with malignant tumors (malignant melanoma, squamous cell carcinoma, Merkel cell tumor, malignant cutaneous lymphoma). The clinical requirements are an invasively growing tumor, problems of self-assurance, and dis-integration of the patient regarding his social and/or professional environment. The decision for a health cure is made by the treating dermatologist in the hospital. In this context, the following sociomedical criteria should be applied: impairment, disability, and handicap. Usually, rehabilitation starts after the patient is discharged from the hospital. The inpatient rehabilitation program should be performed at an institution capable of providing dermatological and psychological treatment. The dermatologist acts as a manager for the members of the rehabilitation team (psychologists, physiotherapists, social workers, and ergo-therapists). In conclusion, dermato-oncologic rehabilitation plays an important role in re-integrating the patient into his professional life to avoid retirement.

  3. Consortium for Health and Military Performance (CHAMP)

    Data.gov (United States)

    Federal Laboratory Consortium — The Center's work addresses a wide scope of trauma exposure from the consequences of combat, operations other than war, terrorism, natural and humanmade disasters,...

  4. Medical Physics Residency Consortium: collaborative endeavors to meet the ABR 2014 certification requirements.

    Science.gov (United States)

    Parker, Brent C; Duhon, John; Yang, Claus C; Wu, H Terry; Hogstrom, Kenneth R; Gibbons, John P

    2014-03-06

    In 2009, Mary Bird Perkins Cancer Center (MBPCC) established a Radiation Oncology Physics Residency Program to provide opportunities for medical physics residency training to MS and PhD graduates of the CAMPEP-accredited Louisiana State University (LSU)-MBPCC Medical Physics Graduate Program. The LSU-MBPCC Program graduates approximately six students yearly, which equates to a need for up to twelve residency positions in a two-year program. To address this need for residency positions, MBPCC has expanded its Program by developing a Consortium consisting of partnerships with medical physics groups located at other nearby clinical institutions. The consortium model offers the residents exposure to a broader range of procedures, technology, and faculty than available at the individual institutions. The Consortium institutions have shown a great deal of support from their medical physics groups and administrations in developing these partnerships. Details of these partnerships are specified within affiliation agreements between MBPCC and each participating institution. All partner sites began resident training in 2011. The Consortium is a network of for-profit, nonprofit, academic, community, and private entities. We feel that these types of collaborative endeavors will be required nationally to reach the number of residency positions needed to meet the 2014 ABR certification requirements and to maintain graduate medical physics training programs.

  5. [Oncologic gynecology and the Internet].

    Science.gov (United States)

    Gizler, Robert; Bielanów, Tomasz; Kulikiewicz, Krzysztof

    2002-11-01

    The strategy of World Wide Web searching for medical sites was presented in this article. The "deep web" and "surface web" resources were searched. The 10 best sites connected with the gynecological oncology, according to authors' opinion, were presented.

  6. American Society of Clinical Oncology

    Science.gov (United States)

    ... of Interest Mobile App Privacy Policy Privacy Policy Social Media Policy Sponsor Policy Terms of Use American Society of Clinical Oncology ASCO Annual Meeting Register and Reserve Your Hotel June 2-6, 2017 | Chicago, Illinois Hotel Reservation & ...

  7. Personalizing medicine in geriatric oncology

    National Research Council Canada - National Science Library

    Walko, Christine M; McLeod, Howard L

    2014-01-01

    Minimizing toxicity while maximizing efficacy is a common goal in the treatment of any condition but its importance is underscored in the discipline of oncology because of the serious nature of many...

  8. Introduction to Neuroscience Peer Review Consortium

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Introduction The Neuroscience Peer Review Consortium is an alliance of neuroscience journals that have agreed to accept manuscript reviews from other members of the Consortium.Its goals are to support efficient and thorough peer review of original research in neuroscience, speed the publication of research reports, and reduce the burden on peer reviewers.

  9. Lessons Learned: Dose Selection of Small Molecule-Targeted Oncology Drugs.

    Science.gov (United States)

    Bullock, Julie M; Rahman, Atiqur; Liu, Qi

    2016-06-01

    Evaluation of dose plays a critical role in a successful oncology development program. Typically for oncology agents, the first-in-man phase I dose-escalation trials are conducted to determine a maximum tolerated dose (MTD). This MTD is taken forward into subsequent trials to establish the safety and efficacy of the drug product. Although this approach was appropriate historically for cytotoxics, the application of MTD as the recommend phase II dose has been problematic for the newer small molecule-targeted oncology agents. Promising alternative approaches using dose and exposure exploration, including lessons learned from recent targeted oncology agent development and approvals, are summarized and discussed. Clin Cancer Res; 22(11); 2630-8. ©2016 AACR SEE ALL ARTICLES IN THIS CCR FOCUS SECTION, "NEW APPROACHES FOR OPTIMIZING DOSING OF ANTICANCER AGENTS".

  10. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update.

    Science.gov (United States)

    Ferrell, Betty R; Temel, Jennifer S; Temin, Sarah; Alesi, Erin R; Balboni, Tracy A; Basch, Ethan M; Firn, Janice I; Paice, Judith A; Peppercorn, Jeffrey M; Phillips, Tanyanika; Stovall, Ellen L; Zimmermann, Camilla; Smith, Thomas J

    2017-01-01

    Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.

  11. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  12. The effect of short term neo-adjuvant androgen deprivation on erectile function in patients treated with external beam radiotherapy for localised prostate cancer: an analysis of the 4- versus 8-month randomised trial (Irish Clinical Oncology Research Group 97-01).

    LENUS (Irish Health Repository)

    Daly, Patricia E

    2012-07-01

    Erectile dysfunction is a common consequence of external beam radiotherapy (EBRT) for prostate cancer. The addition of neo-adjuvant androgen deprivation (NAD) has an indeterminate additive effect. We examined the long-term effect on erectile function (EF) of two durations (4 months: arm 1 and 8 months: arm 2) of NAD prior to radiation (RT) for patients with localised prostate cancer from the Irish Clinical Oncology Research Group (ICORG 97-01) 4- versus 8-month trial. In this study we aimed to (1) analyse the overall effect on EF of NAD in an EBRT population, (2) compare the probability of retained EF over time in an EBRT population treated with either 4 or 8 months of NAD and (3) identify any variables such as risk group and age which may have an additive detrimental effect. This analysis provides unique long term follow up data.

  13. [Unproven methods in oncology].

    Science.gov (United States)

    Jallut, O; Guex, P; Barrelet, L

    1984-09-08

    As in some other chronic diseases (rheumatism, multiple sclerosis, etc.), unproven methods of diagnosis and treatment have long been current in cancer. Since 1960 the American Cancer Society has published an abundant literature on these "unproven methods", which serves as a basis for a historical review: some substances (Krebiozen, Laetrile) have enjoyed tremendous if shortlived success. The present trend is back to nature and "mild medicine". The proponents of this so-called natural medicine are often disciples of a pseudoscientific religion using irrational arguments. Direct attacks on these erroneous theories and their public refutation fail to convince the adepts, who trust in these methods and are not amenable to a scientific approach. Study of their psychological motivations reveals that in fact they seek something more reassuring than plain medical explanation which is aware of its limits. They feel reassured by theories which often bear some resemblance to the old popular medicine. To protect patients against these dangerous methods and all the disillusionment they entail, the Swiss Society of Oncology and the Swiss Cancer League have decided to gather information and draw up a descriptive list of the commonest unproven methods in Switzerland (our File No. 2, "Total anti-cancer cure", is given as an example). The files are published in French, German and English and are available to physicians, nursing teams, and also patients who wish to have more objective information on these methods.

  14. [Economic limits in oncology].

    Science.gov (United States)

    Hellriegel, K P

    2000-12-01

    Economic aspects require consideration even in oncology. However, they have to be seen in context with open questions concerning especially the evaluation of therapeutic effectiveness, of methodology, and particularly of ethics. Medical procedures and achievements should primarily be measured against objective results, against effectiveness and benefits. Consequently, the suitability of diagnostic and therapeutic strategies has to be evaluated. Overall objective of medical achievements should be their optimalization, not their maximization. For a physician being aware of his responsibility, the optimal care for his patients always has highest priority. Medical guidelines for diagnosis, treatment and follow-up are the basis for effective and economic patient care. They have to undergo economic evaluation and permanent updating. For systematic collection, documentation and evaluation, the clinical register is the appropriate instrument. For the assessment of medical care, a continuous monitoring of its processes has to be established. The documentation of medical care processes should lead to sustainable cost reductions together with an optimalization of the quality of care.

  15. Micronutrients in Oncological Intervention

    Directory of Open Access Journals (Sweden)

    Uwe Gröber

    2016-03-01

    Full Text Available Nutritional supplements are widely used among patients with cancer who perceive them to be anticancer and antitoxicity agents. Depending on the type of malignancy and the gender 30%–90% of the cancer patients supplement their diets with antioxidant and immuno-stabilizing micronutrients, such as selenium, vitamin C, and vitamin D, often without the knowledge of the treating physician. From the oncological viewpoint, there are justifiable concerns that dietary supplements decrease the effectiveness of chemotherapy and radiotherapy. Recent studies, however, have provided increasing evidence that treatment is tolerated better—with an increase in patient compliance and a lower rate of treatment discontinuations—when micronutrients, such as selenium, are added as appropriate to the patient’s medication. Nutritional supplementation tailored to an individual’s background diet, genetics, tumor histology, and treatments may yield benefits in subsets of patients. Clinicians should have an open dialogue with patients about nutritional supplements. Supplement advice needs to be individualized and come from a credible source, and it is best communicated by the physician.

  16. Pharmacogenomics in Oncology Care

    Directory of Open Access Journals (Sweden)

    Kelly K Filipski

    2014-04-01

    Full Text Available Cancer pharmacogenomics have contributed a number of important discoveries to current cancer treatment, changing the paradigm of treatment decisions. Both somatic and germline mutations are utilized to better understand the underlying biology of cancer growth and treatment response. The level of evidence required to fully translate pharmacogenomic discoveries into the clinic has relied heavily on randomized clinical trials. In this review, the use of observational studies, as well as, the use of adaptive trials and next generation sequencing to develop the required level of evidence for clinical implementation are discussed.

  17. 直肠癌腹腔镜与开腹手术肿瘤清除及远期疗效的随机对照试验荟萃分析%Meta-analysis of randomized controlled trials comparing laparoscopic with open surgery for rectal cancer on oncologic clearance and long-term oncologic outcomes

    Institute of Scientific and Technical Information of China (English)

    黄美近; 彭慧; 王辉; 梁景琳; 饶本强; 康亮; 张兴伟; 汪建平

    2011-01-01

    目的 探讨腹腔镜手术治疗直肠癌的肿瘤清除情况及长期疗效。方法 利用电子数据库和手工检索等方法检索Pubmed,Embase,Web of Science及Cochrane Library截止至2010年6月30日的所有随机对照试验(RCT)文献。评价指标为淋巴结获取数、肿瘤长期疗效(局部复发、切口复发、总体复发、总体生存率及无病生存率)。采用固定效应模型和随机效应模型对直肠癌腹腔镜手术与开腹手术的肿瘤清除情况及长期疗效指标进行荟萃分析。结果 符合入选标准的RCT文献有6项共计1033例患者,腹腔镜手术组与开腹手术组分别为577例和456例。两组的淋巴结获取数差异无统计学意义(WMD=-0.38,95% CI:-1.35~0.58,P=0.43)。腹腔镜组环周切缘阳性率(7.94%)高于开腹手术组(5.37%),但差异无统计学意义[风险比(RR)=1.13,95% CI:0.69~1.85,P=0.63]。局部复发率比较,差异无统计学意义(RR=0.55,95% CI:0.22~1.40,P=0.21)。两组3年总体生存率比较[危险比(HR)=0.76,95% CI:0.54~1.07,P=0.11],差异无统计学意义;两组3年无病生存率比较(HR=1.16,95% CI:0.61~2.20,P=0.64),差异亦无统计学意义。结论 直肠癌腹腔镜手术在肿瘤清除及长期疗效方面至少与开腹手术相当。%Objective To compare oncologic adequacy of resection and long-term oncologic outcomes between laparoscopic-assisted surgery (LS) and open surgery (OS) in the treatment of rectal cancer. Methods Literature searches of electronic databases (PubMed, Embase, Web of Science,and Cochrane Library) and manual searches up to June 30,2010 were performed to identify RCTs comparing values of oncologic adequacy of resection, recurrence and survival following LS and OS. Fixed and random effects models were used. Results Six RCTs enrolling 1033 participants (LS group:577 cases,OS group:456 cases)were included in the meta-analysis. Number of lymph node harvested was

  18. Oocyte cryopreservation in oncological patients.

    Science.gov (United States)

    Porcu, Eleonora; Fabbri, Raffaella; Damiano, Giuseppe; Fratto, Rosita; Giunchi, Susanna; Venturoli, Stefano

    2004-04-05

    The use of chemotherapy and radiotherapy in oncological patients may reduce their reproductive potential. Sperm cryopreservation has been already used in men affected by neoplastic disease. Oocyte cryopreservation might be an important solution for these patients at risk of losing ovarian function. A program of oocyte cryopreservation for oncological patients is also present in our center. From June 1996 to January 2000, 18 patients awaiting chemotherapy and radiotherapy for neoplastic disease were included in our oocyte cryopreservation program. Our experience documents that oocyte storage may be a concrete and pragmatic alternative for oncological patients. The duration of oocyte storage does not seem to interfere with oocyte survival as pregnancies occurred even after several years of gamete cryopreservation in liquid nitrogen.

  19. Multidisciplinary care in pediatric oncology

    Directory of Open Access Journals (Sweden)

    Cantrell MA

    2011-05-01

    Full Text Available Mary Ann Cantrell1, Kathy Ruble21College of Nursing, Villanova University, Villanova, PA, USA; 2Department of Pediatric Oncology, Johns Hopkins University, School of Medicine, Baltimore, MD, USAAbstract: This paper describes the significant advances in the treatment of childhood cancer and supportive care that have occurred over the last several decades and details how these advances have led to improved survival and quality of life (QOL for children with cancer through a multidisciplinary approach to care. Advances in the basic sciences, general medicine, cooperative research protocols, and policy guidelines have influenced and guided the multidisciplinary approach in pediatric oncology care across the spectrum from diagnosis through long-term survival. Two case studies are provided to highlight the nature and scope of multidisciplinary care in pediatric oncology care.Keywords: childhood cancer, chemotherapy, leukemia

  20. Personality types of oncology nurses.

    Science.gov (United States)

    Bean, C A; Holcombe, J K

    1993-12-01

    Personality type influences the choice of occupation. The breadth of specialty areas within oncology nursing allows for divergent activities and relationships and, thus, the accommodation of different personality characteristics. This exploratory study examined personality types for a convenience sample of oncology nurses predominantly employed in hospitals. According to the personality typology defined by Carl Jung, a person demonstrates a preference among four dimensions, i.e., extraversion/introversion, sensory/intuition, thinking/feeling, and judging/perceiving. The type with the strongest self-selection for these oncology nurses was ISFJ, where feeling is introverted and perception is practical, so that helping others is both a responsibility and a pleasure. The discussion relates the personality types to Jung's theory and their impact in clinical practice. Strengths and weaknesses of each personality type are described.

  1. Systematic in-vitro evaluation of the NCI/NIH Developmental Therapeutics Program Approved Oncology Drug Set for the identification of a candidate drug repertoire for MLL-rearranged leukemia

    Directory of Open Access Journals (Sweden)

    Hoeksema KA

    2011-09-01

    Full Text Available Kimberley A Hoeksema1, Aarthi Jayanthan1, Todd Cooper2, Lia Gore3, Tanya Trippett4, Jessica Boklan6, Robert J Arceci5, Aru Narendran11Division of Pediatric Oncology, Alberta Children's Hospital, Calgary, AB, Canada; 2Aflac Cancer Center and Blood Disorders Service, Children's Healthcare of Atlanta, Emory University, Atlanta, GA, USA; 3Center for Cancer and Blood Disorders, Children's Hospital, University of Colorado Denver, Aurora, CO, USA; 4Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 5Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA; 6Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, AZ, USAAbstract: Despite significant progress made in the overall cure rate, the prognosis for relapsed and refractory malignancies in children remains extremely poor. Hence, there is an urgent need for studies that enable the timely selection of appropriate agents for Phase I clinical studies. The Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC is systematically evaluating libraries of known and novel compounds for activity against subsets of high-risk pediatric malignancies with defined molecular aberrations for future clinical development. In this report, we describe the in-vitro activity of a diverse panel of approved oncology drugs against MLL-rearranged pediatric leukemia cell lines. Agents in the Approved Oncology Drug Set II (National Cancer Institute/National Institutes of Health Developmental Therapeutics Program were evaluated by in-vitro cytotoxicity assays in pediatric acute lymphoblastic leukemia and acute myeloid leukemia cell lines with MLL gene rearrangements. Validation studies were carried out with patient leukemia cells in culture. Comparative analysis for toxicity against nonmalignant cells was evaluated in normal bone marrow stromal cells and normal human lymphocytes. Results from this study show that 42 of the 89 agents tested have

  2. Palliative medicine and medical oncology.

    Science.gov (United States)

    Maltoni, M; Amadori, D

    2001-04-01

    Traditionally, medical oncology and palliative care have been considered two distinct and separate disciplines, both as regards treatment objectives and delivery times. Palliative care in terminal stages, aimed exclusively at evaluating and improving quality of life, followed antitumor therapies, which concentrated solely on quantitative results (cure, prolongation of life, tumoral mass shrinkage). Over the years, more modern concepts have developed on the subject. Medical oncology, dealing with the skills and strategic co-ordination of oncologic interventions from primary prevention to terminal phases, should also include assessment and treatment of patients' subjective needs. Anticancer therapies should be evaluated in terms of both the quantitative and qualititative impact on patients' lives. Hence, the traditional view of palliative care has to be modified: it constitutes a philosophical and methodological approach to be adopted from the early phases of illness. It is not the evident cultural necessity of integrating medical oncology with palliative medicine that may be a matter of argument, but rather the organizational models needed to put this combined care into practice: should continuous care be guaranteed by a single figure, the medical oncologist, or rather by an interdisciplinary providers' team, including full-time doctors well-equipped for palliative care? In this paper the needs of cancer patients and the part that a complete oncologist should play to deal with such difficult and far-reaching problems are firstly described. Then, as mild provocation, data and critical considerations on the ever increasing needs of palliative care, the present shortcomings in quality of life and pain assessment and management by medical oncologists, and the uncertain efficacy of interventional programmes to change clinical practice are described. Finally, a model of therapeutic continuity is presented. which in our view is realistic and feasible: an Oncologic

  3. Advances in radiation oncology in new millennium in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Huh, Seung Jae [College of Medicine, Sungkyunkwan Univ., Seoul (Korea, Republic of); Park, Charn Il [College of Medicine, Seoul National Univ., Seoul (Korea, Republic of)

    2000-06-01

    The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy. IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally pattems-of-care study about major cancers.

  4. Geriatric oncology in the Netherlands: a survey of medical oncology specialists and oncology nursing specialists.

    Science.gov (United States)

    Jonker, J M; Smorenburg, C H; Schiphorst, A H; van Rixtel, B; Portielje, J E A; Hamaker, M E

    2014-11-01

    To identify ways to improve cancer care for older patients, we set out to examine how older patients in the Netherlands are currently being evaluated prior to oncological treatment and to explore the potential obstacles in the incorporation of a geriatric evaluation, using a web-based survey sent to Dutch medical oncology specialists and oncology nursing specialists. The response rate was 34% (183 out of 544). Two-thirds of respondents reported that a geriatric evaluation was being used, although primarily on an ad hoc basis only. Most respondents expressed a desire for a routine evaluation or more intensive collaboration with the geriatrician and 86% of respondents who were not using a geriatric evaluation expressed their interest to do so. The most important obstacles were a lack of time or personnel and insufficient availability of a geriatrician to perform the assessment. Thus, over 30% of oncology professionals in the Netherlands express an interest in geriatric oncology. Important obstacles to a routine implementation of a geriatric evaluation are a lack of time, or insufficient availability of geriatricians; this could be overcome with policies that acknowledge that quality cancer care for older patients requires the investment of time and personnel.

  5. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... plans for four products that are in development for an adult oncology indication. The subcommittee...

  6. 75 FR 66773 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-29

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... were either recently approved by FDA or, are in late stage development for an adult oncology...

  7. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... ] (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... relevance and potential use of such measures in the pediatric development plans of oncology products....

  8. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of... late stage development for various adult oncology indications. The subcommittee will consider...

  9. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-05

    ... HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee of..., are in late stage development for an adult oncology indication, or in late stage development...

  10. PET/MR in oncology

    DEFF Research Database (Denmark)

    Balyasnikova, Svetlana; Löfgren, Johan; de Nijs, Robin

    2012-01-01

    of the challenges inherent in this new technology, but focus on potential applications for simultaneous PET/MR in the field of oncology. Methods and tracers for use with the PET technology will be familiar to most readers of this journal; thus this paper aims to provide a short and basic introduction to a number...... be applied together with PET increasing the amount of information about the tissues of interest. The potential clinical benefit of applying PET/MR in staging, radiotherapy planning and treatment evaluation in oncology, as well as the research perspectives for the use of PET/MR in the development of new...

  11. Global Health in Radiation Oncology

    DEFF Research Database (Denmark)

    Rodin, Danielle; Yap, Mei Ling; Grover, Surbhi

    2017-01-01

    The massive global shortfall in radiotherapy equipment and human resources in developing countries is an enormous challenge for international efforts in cancer control. This lack of access to treatment has been long-standing, but there is now a growing consensus about the urgent need to prioritize...... programs. However, formalized training and career promotion tracks in global health within radiation oncology have been slow to emerge, thereby limiting the sustained involvement of students and faculty, and restricting opportunities for leadership in this space. We examine here potential structures...... and funding models might be used to further develop and expand radiation oncology services globally....

  12. PET/MR in oncology

    DEFF Research Database (Denmark)

    Balyasnikova, Svetlana; Löfgren, Johan; de Nijs, Robin

    2012-01-01

    of the challenges inherent in this new technology, but focus on potential applications for simultaneous PET/MR in the field of oncology. Methods and tracers for use with the PET technology will be familiar to most readers of this journal; thus this paper aims to provide a short and basic introduction to a number...... be applied together with PET increasing the amount of information about the tissues of interest. The potential clinical benefit of applying PET/MR in staging, radiotherapy planning and treatment evaluation in oncology, as well as the research perspectives for the use of PET/MR in the development of new...

  13. International Lymphoma Epidemiology Consortium (InterLymph)

    Science.gov (United States)

    A consortium designed to enhance collaboration among epidemiologists studying lymphoma, to provide a forum for the exchange of research ideas, and to create a framework for collaborating on analyses that pool data from multiple studies

  14. NASA Space Radiation Transport Code Development Consortium.

    Science.gov (United States)

    Townsend, Lawrence W

    2005-01-01

    Recently, NASA established a consortium involving the University of Tennessee (lead institution), the University of Houston, Roanoke College and various government and national laboratories, to accelerate the development of a standard set of radiation transport computer codes for NASA human exploration applications. This effort involves further improvements of the Monte Carlo codes HETC and FLUKA and the deterministic code HZETRN, including developing nuclear reaction databases necessary to extend the Monte Carlo codes to carry out heavy ion transport, and extending HZETRN to three dimensions. The improved codes will be validated by comparing predictions with measured laboratory transport data, provided by an experimental measurements consortium, and measurements in the upper atmosphere on the balloon-borne Deep Space Test Bed (DSTB). In this paper, we present an overview of the consortium members and the current status and future plans of consortium efforts to meet the research goals and objectives of this extensive undertaking.

  15. International Radical Cystectomy Consortium: A way forward

    Directory of Open Access Journals (Sweden)

    Syed Johar Raza

    2014-01-01

    Full Text Available Robot-assisted radical cystectomy (RARC is an emerging operative alternative to open surgery for the management of invasive bladder cancer. Studies from single institutions provide limited data due to the small number of patients. In order to better understand the related outcomes, a world-wide consortium was established in 2006 of patients undergoing RARC, called the International Robotic Cystectomy Consortium (IRCC. Thus far, the IRCC has reported its findings on various areas of operative interest and continues to expand its capacity to include other operative modalities and transform it into the International Radical Cystectomy Consortium. This article summarizes the findings of the IRCC and highlights the future direction of the consortium.

  16. The LBNL/JSU/AGMUS Science Consortium

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-04-01

    This report discusses the 11 year of accomplishments of the science consortium of minority graduates from Jackson State University and Ana G. Mendez University at the Lawrence Berkeley National Laboratory.

  17. Gene Ontology Consortium: going forward.

    Science.gov (United States)

    2015-01-01

    The Gene Ontology (GO; http://www.geneontology.org) is a community-based bioinformatics resource that supplies information about gene product function using ontologies to represent biological knowledge. Here we describe improvements and expansions to several branches of the ontology, as well as updates that have allowed us to more efficiently disseminate the GO and capture feedback from the research community. The Gene Ontology Consortium (GOC) has expanded areas of the ontology such as cilia-related terms, cell-cycle terms and multicellular organism processes. We have also implemented new tools for generating ontology terms based on a set of logical rules making use of templates, and we have made efforts to increase our use of logical definitions. The GOC has a new and improved web site summarizing new developments and documentation, serving as a portal to GO data. Users can perform GO enrichment analysis, and search the GO for terms, annotations to gene products, and associated metadata across multiple species using the all-new AmiGO 2 browser. We encourage and welcome the input of the research community in all biological areas in our continued effort to improve the Gene Ontology. © The Author(s) 2014. Published by Oxford University Press on behalf of Nucleic Acids Research.

  18. Gene Ontology Consortium: going forward

    Science.gov (United States)

    2015-01-01

    The Gene Ontology (GO; http://www.geneontology.org) is a community-based bioinformatics resource that supplies information about gene product function using ontologies to represent biological knowledge. Here we describe improvements and expansions to several branches of the ontology, as well as updates that have allowed us to more efficiently disseminate the GO and capture feedback from the research community. The Gene Ontology Consortium (GOC) has expanded areas of the ontology such as cilia-related terms, cell-cycle terms and multicellular organism processes. We have also implemented new tools for generating ontology terms based on a set of logical rules making use of templates, and we have made efforts to increase our use of logical definitions. The GOC has a new and improved web site summarizing new developments and documentation, serving as a portal to GO data. Users can perform GO enrichment analysis, and search the GO for terms, annotations to gene products, and associated metadata across multiple species using the all-new AmiGO 2 browser. We encourage and welcome the input of the research community in all biological areas in our continued effort to improve the Gene Ontology. PMID:25428369

  19. Oncological emergencies for the internist

    Directory of Open Access Journals (Sweden)

    Umesh Das

    2015-01-01

    Full Text Available An oncologic emergency is defined as any acute, potentially life-threatening event, either directly or indirectly related to a patient′s cancer (ca or its treatment. It requires rapid intervention to avoid death or severe permanent damage. Most oncologic emergencies can be classified as metabolic, hematologic, structural, or side effects from chemotherapy agents. Tumor lysis syndrome is a metabolic emergency that presents as severe electrolyte abnormalities. The condition is treated with aggressive hydration, allopurinol or urate oxidase to lower uric acid levels. Hypercalcemia of malignancy is treated with aggressive rehydration, furosemide, and intravenous (IV bisphosphonates. Syndrome of inappropriate antidiuretic hormone should be suspected if a patient with ca presents with normovolemic hyponatremia. This metabolic condition usually is treated with fluid restriction and furosemide. Febrile neutropenia is a hematologic emergency that usually requires inpatient therapy with broad-spectrum antibiotics, although outpatient therapy may be appropriate for low-risk patients. Hyperviscosity syndrome usually is associated with Waldenstrφm′s macroglobulinemia, which is treated with plasmapheresis and chemotherapy. Structural oncologic emergencies are caused by direct compression of surrounding structures or by metastatic disease. Superior vena cava syndrome is the most common structural oncological emergency. Treatment options include chemotherapy, radiation, and IV stenting. Epidural spinal cord compression can be treated with dexamethasone, radiation, or surgery. Malignant pericardial effusion, which often is undiagnosed in ca patients, can be treated with pericardiocentesis or a pericardial window procedure.

  20. Exploring targeted therapies in oncology

    NARCIS (Netherlands)

    Mom, Constantijne Helene

    2007-01-01

    Targeted therapy in oncology is treatment directed at specific biological pathways and processes that play a critical role in carcinogenesis. Increased knowledge regarding the molecular changes underlying tumor progression and metastatis has resulted in the development of agents that are designed to

  1. [What's new in geriatric oncology?].

    Science.gov (United States)

    Terret, Catherine; Albrand, Gilles; Jeanton, Martine; Courpron, Philippe; Droz, Jean-Pierre

    2006-01-01

    Remarkably, although 60% of new cancer cases and over 70% of cancer deaths occur in patients aged 65 years and older in Europe, standard treatment strategies have been mostly validated in younger adults. This demographic trend has led to the emergence of a new medical discipline, geriatric oncology and the development worldwide of geriatric oncology programs for the individualized management of elderly cancer patients. Elderly cancer patients represent an increasing share of the population and strategies for treating cancer must evolve to face this ineluctable reality. Treatment should take into account the highly heterogeneous physiological age of the elderly, their individual life expectancy, functional reserves, social support and preferences. French geriatric oncology programs have been mostly based on the interdependence of geriatricians, oncologists and auxiliary nursing people. This approach represent the best way to offer patients optimal management; oncologists and geriatricians collaborate to assess both global health status by means of Comprehensive Geriatric Assessment (CGA) and tumor stage by means of Comprehensive Tumor Assessment (CTA) and to initiate individualized care plans, involving comprehensive management and follow-up of all identified problems. This paper focuses on progress observed in the field of geriatric oncology both in France and worldwide.

  2. [History of Oncology in Slovakia].

    Science.gov (United States)

    Ondruš, D; Kaušitz, J

    2016-01-01

    The history of oncology in Slovakia is closely linked to the history of St. Elizabeth Hospital, which was set up in the mid-18th century by nuns of the St. Elizabeth Order in Bratislava. In the first half of the 20th century, a unit was set up in the hospital dedicated to diagnosis and treatment of cancer. Shortly after World War II, the unit was turned into the Institute for Cancer Research and Treatment. In 1950, St. Elizabeth Hospital was nationalized, and the Cancer Research Institute of the Slovak Academy of Science and the Institute of Clinical Oncology were located there as centers for oncological diagnosis and treatment. After the restitution of church property in the early 1990s, the hospital was returned to the Order of St. Elizabeth, which set up the St. Elisabeth Cancer Institute in the hospital premises in January of 1996. This year marks the 20th anniversary of this institute in its new premises and the 85th anniversary of the Institute of Radiumtherapy founded in Bratislava, and thus the establishment of institutional healthcare for cancer patients in Slovakia is the reason for balancing. We present a view of the consecutive changes in the organization, space and staff of the Institute and evaluate the impact of celebrities on medicine who developed oncology as a clinical, scientific and educational discipline in Bratislava and in other cities and regions of Slovakia.

  3. Precision medicine in oncology drug development: a pharma perspective.

    Science.gov (United States)

    Hollingsworth, Simon J

    2015-12-01

    A rapid expansion in precision medicine founded on the potential for durable clinical benefit through matching a drug to a predictive marker used to select patients has driven the development of targeted drugs with accompanied companion diagnostics for patient selection. Oncology has been at the forefront, with the improvements in patient survival notable. Increasing numbers of molecular subgroups require an equally increasing number (and new generation) of highly selective agents targeting inevitably lower incidence molecular segments, posing significant challenges for drug development. Innovative trial designs (umbrella or basket studies) are emerging as patient-centric approaches and public-private partnerships, cross-industry, government and non-profit sector collaborations are enabling implementation. Success will require continued innovation, new paradigms in oncology drug development and market approval and continued collaboration. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Antisense therapeutics in oncology: current status

    Directory of Open Access Journals (Sweden)

    Farooqi AA

    2014-11-01

    Full Text Available Ammad Ahmad Farooqi,1 Zia ur Rehman,2 Jordi Muntane3,4 1Laboratory for Translational Oncology and Personalized Medicine, Rashid Latif Medical College, Lahore, Pakistan; 2Department of Biotechnology and Genetic Engineering, Kohat University of Science and Technology (KUST, Kohat, Pakistan; 3Department of General Surgery, Institute of Biomedicine of Seville (IBiS, Hospital Universitary "Virgen del Rocío"/CSIC/University of Seville, Sevilla, Spain; 4Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD o Ciberehd, Instituto de Salud Carlos III, Spain Abstract: There is increasing progress in translational oncology and tremendous breakthroughs have been made as evidenced by preclinical and clinical trials. Data obtained from high-throughput technologies are deepening our understanding about the molecular and gene network in cancer cells and rapidly emerging in vitro and in vivo evidence is highlighting the role of antisense agents as specific inhibitors of the expression of target genes, thus modulating the response of cancer cells to different therapeutic strategies. Much information is continuously being added into various facets of molecular oncology and it is now understood that overexpression of antiapoptotic proteins, oncogenes, oncogenic microRNAs (miRNA, and fusion proteins make cancer cells difficult to target. Delivery of antisense oligonucleotides has remained a challenge and technological developments have helped in overcoming hurdles by improving the ability to penetrate cells, effective and targeted binding to gene sequences, and downregulation of target gene function. Different delivery systems, including stable nucleic acid lipid particles, have shown potential in enhancing the delivery of cargo to the target site. In this review, we attempt to summarize the current progress in the development of antisense therapeutics and their potential in medical research. We partition this multicomponent

  5. Emerging concepts in biomarker discovery; the US-Japan Workshop on Immunological Molecular Markers in Oncology.

    Science.gov (United States)

    Tahara, Hideaki; Sato, Marimo; Thurin, Magdalena; Wang, Ena; Butterfield, Lisa H; Disis, Mary L; Fox, Bernard A; Lee, Peter P; Khleif, Samir N; Wigginton, Jon M; Ambs, Stefan; Akutsu, Yasunori; Chaussabel, Damien; Doki, Yuichiro; Eremin, Oleg; Fridman, Wolf Hervé; Hirohashi, Yoshihiko; Imai, Kohzoh; Jacobson, James; Jinushi, Masahisa; Kanamoto, Akira; Kashani-Sabet, Mohammed; Kato, Kazunori; Kawakami, Yutaka; Kirkwood, John M; Kleen, Thomas O; Lehmann, Paul V; Liotta, Lance; Lotze, Michael T; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Matsubara, Hisahiro; Mayrand-Chung, Shawmarie; Nakamura, Kiminori; Nishikawa, Hiroyoshi; Palucka, A Karolina; Petricoin, Emanuel F; Pos, Zoltan; Ribas, Antoni; Rivoltini, Licia; Sato, Noriyuki; Shiku, Hiroshi; Slingluff, Craig L; Streicher, Howard; Stroncek, David F; Takeuchi, Hiroya; Toyota, Minoru; Wada, Hisashi; Wu, Xifeng; Wulfkuhle, Julia; Yaguchi, Tomonori; Zeskind, Benjamin; Zhao, Yingdong; Zocca, Mai-Britt; Marincola, Francesco M

    2009-06-17

    might be added to the list of known entities applicable in immunotherapy trials. The need for a systematic approach to biomarker discovery that takes advantage of powerful high-throughput technologies was recognized; it was clear from the current state of the science that immunotherapy is still in a discovery phase and only a few of the current biomarkers warrant extensive validation. It was, finally, clear that, while current technologies have almost limitless potential, inadequate study design, limited standardization and cross-validation among laboratories and suboptimal comparability of data remain major road blocks. The institution of an interactive consortium for high throughput molecular monitoring of clinical trials with voluntary participation might provide cost-effective solutions.

  6. Emerging concepts in biomarker discovery; The US-Japan workshop on immunological molecular markers in oncology

    Directory of Open Access Journals (Sweden)

    Rivoltini Licia

    2009-06-01

    were recognized that might be added to the list of known entities applicable in immunotherapy trials. The need for a systematic approach to biomarker discovery that takes advantage of powerful high-throughput technologies was recognized; it was clear from the current state of the science that immunotherapy is still in a discovery phase and only a few of the current biomarkers warrant extensive validation. It was, finally, clear that, while current technologies have almost limitless potential, inadequate study design, limited standardization and cross-validation among laboratories and suboptimal comparability of data remain major road blocks. The institution of an interactive consortium for high throughput molecular monitoring of clinical trials with voluntary participation might provide cost-effective solutions.

  7. A Phase 2 Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy After Surgery in Patients With High-Risk Endometrial Cancer: A Korean Gynecologic Oncologic Group Study

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Hanbyoul [Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Women' s Life Medical Science, Yonsei University College of Medicine, Seoul (Korea, Republic of); Nam, Byung-Ho [Cancer Biostatistics Branch, Research Institute for National Cancer Control and Evaluation, National Cancer Center, Goyang (Korea, Republic of); Kim, Seok Mo [Department of Obstetrics and Gynecology, Chonnam National University School of Medicine, Gwangju (Korea, Republic of); Cho, Chi-Heum [Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu (Korea, Republic of); Kim, Byoung Gie [Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); Ryu, Hee-Sug [Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon (Korea, Republic of); Kang, Soon Beom [Department of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul (Korea, Republic of); Kim, Jae-Hoon, E-mail: jaehoonkim@yuhs.ac [Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Institute of Women' s Life Medical Science, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2014-09-01

    Purpose: A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer. Methods and Materials: Pathologic requirements included endometrial endometrioid adenocarcinoma stages III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5 fractions per week for 6 weeks. Paclitaxel 60 mg/m{sup 2} was administered once weekly for 5 weeks during radiation therapy. Results: Fifty-seven patients were enrolled between January 2006 and March 2008. The median follow-up time was 60.0 months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were hematologic and usually self-limited. There was no life-threatening toxicity. The cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The estimated 5-year disease-free and overall survival rates were 63.5% (95% CI, 50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively. Conclusions: Concurrent chemoradiation with weekly paclitaxel is well tolerated and seems to be effective for high-risk endometrioid endometrial cancers. This approach appears reasonable to be tested for efficacy in a prospective, randomized controlled study.

  8. Topotecan and cisplatin in combination with concurrent twice-daily chemoradiation in limited disease small cell lung cancer-a Danish Oncological Lung Cancer Group (DOLG) phase II trial

    DEFF Research Database (Denmark)

    Sorensen, Morten; Lassen, Ulrik; Palshof, Torben

    2007-01-01

    INTRODUCTION: The longest survival time reported in randomised trials of limited disease (LD) SCLC has been achieved with early twice-daily concurrent chemoradiation. Topotecan is active in recurrent SCLC and in extensive disease as first line treatment. Aim: To incorporate and assess the effect...

  9. Raman Spectroscopy for Clinical Oncology

    Directory of Open Access Journals (Sweden)

    Michael B. Fenn

    2011-01-01

    Full Text Available Cancer is one of the leading causes of death throughout the world. Advancements in early and improved diagnosis could help prevent a significant number of these deaths. Raman spectroscopy is a vibrational spectroscopic technique which has received considerable attention recently with regards to applications in clinical oncology. Raman spectroscopy has the potential not only to improve diagnosis of cancer but also to advance the treatment of cancer. A number of studies have investigated Raman spectroscopy for its potential to improve diagnosis and treatment of a wide variety of cancers. In this paper the most recent advances in dispersive Raman spectroscopy, which have demonstrated promising leads to real world application for clinical oncology are reviewed. The application of Raman spectroscopy to breast, brain, skin, cervical, gastrointestinal, oral, and lung cancers is reviewed as well as a special focus on the data analysis techniques, which have been employed in the studies.

  10. A Phase 3 Trial of Whole Brain Radiation Therapy and Stereotactic Radiosurgery Alone Versus WBRT and SRS With Temozolomide or Erlotinib for Non-Small Cell Lung Cancer and 1 to 3 Brain Metastases: Radiation Therapy Oncology Group 0320

    Energy Technology Data Exchange (ETDEWEB)

    Sperduto, Paul W., E-mail: psperduto@mropa.com [Metro MN CCOP, Minneapolis, Minnesota (United States); Wang, Meihua [RTOG Statistical Center, Philadelphia, Pennsylvania (United States); Robins, H. Ian [University of Wisconsin Medical School Cancer Center, Madison, Wisconsin (United States); Schell, Michael C. [Wilmot Cancer Center, University of Rochester, Rochester, New York (United States); Werner-Wasik, Maria [Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Komaki, Ritsuko [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Souhami, Luis [McGill University, Montreal, Quebec (Canada); Buyyounouski, Mark K. [Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Khuntia, Deepak [University of Wisconsin Hospital, Madison, Wisconsin (United States); Demas, William [Akron City Hospital, Akron, Ohio (United States); Shah, Sunjay A. [Christiana Care Health Services, Inc, CCOP, Newark, Delaware (United States); Nedzi, Lucien A. [University of Texas Southwestern Medical School, Dallas, Texas (United States); Perry, Gad [The Ottawa Hospital Cancer Centre, Ottawa, Ontario (Canada); Suh, John H. [Cleveland Clinic Foundation, Cleveland, Ohio (United States); Mehta, Minesh P. [Northwestern Memorial Hospital, Chicago, Illinois (United States)

    2013-04-01

    Background: A phase 3 Radiation Therapy Oncology Group (RTOG) study subset analysis demonstrated improved overall survival (OS) with the addition of stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT) in non-small cell lung cancer (NSCLC) patients with 1 to 3 brain metastases. Because temozolomide (TMZ) and erlotinib (ETN) cross the blood-brain barrier and have documented activity in NSCLC, a phase 3 study was designed to test whether these drugs would improve the OS associated with WBRT + SRS. Methods and Materials: NSCLC patients with 1 to 3 brain metastases were randomized to receive WBRT (2.5 Gy × 15 to 37.5 Gy) and SRS alone, versus WBRT + SRS + TMZ (75 mg/m{sup 2}/day × 21 days) or ETN (150 mg/day). ETN (150 mg/day) or TMZ (150-200 mg/m{sup 2}/day × 5 days/month) could be continued for as long as 6 months after WBRT + SRS. The primary endpoint was OS. Results: After 126 patients were enrolled, the study closed because of accrual limitations. The median survival times (MST) for WBRT + SRS, WBRT + SRS + TMZ, and WBRT + SRS + ETN were qualitatively different (13.4, 6.3, and 6.1 months, respectively), although the differences were not statistically significant. Time to central nervous system progression and performance status at 6 months were better in the WBRT + SRS arm. Grade 3 to 5 toxicity was 11%, 41%, and 49% in arms 1, 2, and 3, respectively (P<.001). Conclusion: The addition of TMZ or ETN to WBRT + SRS in NSCLC patients with 1 to 3 brain metastases did not improve survival and possibly had a deleterious effect. Because the analysis is underpowered, these data suggest but do not prove that increased toxicity was the cause of inferior survival in the drug arms.

  11. Dummy Run of Quality Assurance Program in a Phase 3 Randomized Trial Investigating the Role of Internal Mammary Lymph Node Irradiation in Breast Cancer Patients: Korean Radiation Oncology Group 08-06 Study

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Yoonsun [Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of); Kim, Jun Won [Department of Radiation Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Shin, Kyung Hwan [Department of Radiation Oncology, Proton Therapy Center, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Kim, Su Ssan [Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul (Korea, Republic of); Ahn, Sung-Ja [Department of Radiation Oncology, Chonnam National University Medical School, Gwangju (Korea, Republic of); Park, Won [Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); Lee, Hyung-Sik [Department of Radiation Oncology, Dong-A University Hospital, Dong-A University School of Medicine, Busan (Korea, Republic of); Kim, Dong Won [Department of Radiation Oncology, Pusan National University Hospital, Pusan National University School of Medicine, Busan (Korea, Republic of); Lee, Kyu Chan [Department of Radiation Oncology, Gachon University Gil Medical Center, Incheon (Korea, Republic of); Suh, Hyun Suk [Department of Radiation Oncology, Ewha Womans University Mokdong Hospital, Seoul (Korea, Republic of); Kim, Jin Hee [Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu (Korea, Republic of); Shin, Hyun Soo [Department of Radiation Oncology, Bundang CHA Hospital, School of Medicine, CHA University, Seongnam (Korea, Republic of); Kim, Yong Bae, E-mail: ybkim3@yuhs.ac [Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of); Suh, Chang-Ok [Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2015-02-01

    Purpose: The Korean Radiation Oncology Group (KROG) 08-06 study protocol allowed radiation therapy (RT) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node (IMN). The purpose of this study was to assess dosimetric differences between the 2 groups and potential influence on clinical outcome by a dummy run procedure. Methods and Materials: All participating institutions were asked to produce RT plans without irradiation (Arm 1) and with irradiation to the IMN (Arm 2) for 1 breast-conservation treatment case (breast-conserving surgery [BCS]) and 1 mastectomy case (modified radical mastectomy [MRM]) whose computed tomography images were provided. We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs. A reference IMN was delineated by an expert panel group based on the study guidelines. Also, we analyzed the potential influence of actual dose variation observed in this study on patient survival. Results: Although physicians intended to exclude the IMN within the RT field, the data showed almost 59.0% of the prescribed dose was delivered to the IMN in Arm 1. However, the mean doses covering the IMN in Arm 1 and Arm 2 were significantly different for both cases (P<.001). Due to the probability of overdose in Arm 1, the estimated gain in 7-year disease-free survival rate would be reduced from 10% to 7.9% for BCS cases and 7.1% for MRM cases. The radiation doses to the ipsilateral lung, heart, and coronary artery were lower in Arm 1 than in Arm 2. Conclusions: Although this dummy run study indicated that a substantial dose was delivered to the IMN, even in the nonirradiation group, the dose differences between the 2 groups were statistically significant. However, this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN

  12. Generalities of the oncological pain

    Directory of Open Access Journals (Sweden)

    Sarah María Regueira Betancourt

    2015-09-01

    Full Text Available Cancer pain can be caused by a malignant tumor, by the therapy used to treat it, or by both causes. It begins with an acute onset that goes towards healing or chronicity. Together with the manifestations of a chronic pain, acute episodes may appear. A bibliographic study was carried out on the oncological pain, using the resources available in the Infomed network, specifically Ebsco, The Cochrane Librery, PubMed, Hinari and SciELO, by means of which the following databases were accessed: MEDLINE, AcademicSearch Premier and MedicLatina. The presence of pain in an oncological process is variable and it depends on the type and extension of the disease, as well as on each person's own individual tolerance. The terminal intense oncological pain is a circumstance both foreseeable and necessarily avoidable. Its relief is a priority in the cancer program of the World Health Organization. To know the classification of pain, its causes, the assessment scales and the way in which it may be described provides a comprehensive treatment for cancer pain. It also helps to optimize the comprehensive care to the patients suffering from this condition and improve their quality of life.

  13. Orthodontic treatment in oncological patients.

    Science.gov (United States)

    Mituś-Kenig, Maria; Łoboda, Magdalena; Marcinkowska-Mituś, Agata; Durka-Zajac, Magdalena; Pawłowska, Elzbieta

    2015-01-01

    The progress in oncological treatment has led to the current increase of childhood cancer survival rate to 80%. That is why orthodontists more and more frequently consult patients who had completed a successful anti-cancer therapy in childhood. Oncological treatments such as chemotherapy, radiotherapy or supportive immunosuppressive therapy cause numerous side effects in growing patients, connected i.a. with growth, the development of teeth or the viscerocranium. This is a special group of patients that needs an optimised plan of orthodontic treatment and often has to accept a compromise result. The purpose of the current work is to discuss the results of orthodontic treatment in patients after an anti-cancer therapy. Time of treatment was 12,5 months. In 6 patients (from 40 undergoing orthodontic therapy) we haven't reached a normocclusion, in 9 patients we should have stopped the therapy because of the recurrence. In 11 patients we found mucosa inflammation and in 1 patient the therapy stopped before the end because of very low oral hygiene level. Bearing in mind the limited number of original works on the above topic in Polish medical literature, the study has been carried out in order to make Polish orthodontists more acquainted with the topic and the standards of dealing with an oncological patient.

  14. Grid Modernization Laboratory Consortium - Testing and Verification

    Energy Technology Data Exchange (ETDEWEB)

    Kroposki, Benjamin; Skare, Paul; Pratt, Rob; Kim, Tom; Ellis, Abraham

    2017-05-11

    This paper highlights some of the unique testing capabilities and projects being performed at several national laboratories as part of the U. S. Department of Energy Grid Modernization Laboratory Consortium. As part of this effort, the Grid Modernization Laboratory Consortium Testing Network isbeing developed to accelerate grid modernization by enablingaccess to a comprehensive testing infrastructure and creating a repository of validated models and simulation tools that will be publicly available. This work is key to accelerating thedevelopment, validation, standardization, adoption, and deployment of new grid technologies to help meet U. S. energy goals.

  15. The COPD Biomarker Qualification Consortium (CBQC)

    DEFF Research Database (Denmark)

    Casaburi, Richard; Celli, Bartolome; Crapo, James

    2013-01-01

    , and no interested party has been in a position to undertake such a process. In order to facilitate the development of novel tools to assess new treatments, the Food and Drug Administration, in collaboration with the COPD Foundation, the National Heart Lung and Blood Institute and scientists from the pharmaceutical...... industry and academia conducted a workshop to survey the available information that could contribute to new tools. Based on this, a collaborative project, the COPD Biomarkers Qualification Consortium, was initiated. The Consortium in now actively preparing integrated data sets from existing resources...... that can address the problem of drug development tools for COPD....

  16. COAL ASH RESOURCES RESEARCH CONSORTIUM

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    The Coal Ash Resources Research Consortium (CARRC, pronounced �cars�) is the core coal combustion by-product (CCB) research group at the Energy & Environmental Research Center (EERC). CARRC focuses on performing fundamental and applied scientific and engineering research emphasizing the environmentally safe, economical use of CCBs. CARRC member organizations, which include utilities and marketers, are key to developing industry-driven research in the area of CCB utilization and ensuring its successful application. CARRC continued the partnership of industry partners, university researchers, and the U.S. Department of Energy (DOE) addressing needs in the CCB industry through technical research and development projects. Technology transfer also continued through distribution and presentation of the results of research activities to appropriate audiences, with emphasis on reaching government agency representatives and end users of CCBs. CARRC partners have evolved technically and have jointly developed an understanding of the layers of social, regulatory, legal, and competition issues that impact the success of CCB utilization as applies to the CCB industry in general and to individual companies. Many CARRC tasks are designed to provide information on CCB performance including environmental performance, engineering performance, favorable economics, and improved life cycle of products and projects. CARRC activities from 1993�1998 included a variety of research tasks, with primary work performed in laboratory tasks developed to answer specific questions or evaluate important fundamental properties of CCBs. The tasks summarized in this report are 1) The Demonstration of CCB Use in Small Construction Projects, 2) Application of CCSEM (computer-controlled scanning electron microscopy) for Coal Combustion By-Product Characterization, 3) Development of a Procedure to Determine Heat of Hydration for Coal Combustion By-Products, 4) Investigation of the Behavior of High

  17. Design, development of water tank-type lung phantom and dosimetric verification in institutions participating in a phase I study of stereotactic body radiation therapy in patients with T2N0M0 non-small cell lung cancer: Japan Clinical Oncology Group trial (JCOG0702).

    Science.gov (United States)

    Nishio, Teiji; Shirato, Hiroki; Ishikawa, Masayori; Miyabe, Yuki; Kito, Satoshi; Narita, Yuichirou; Onimaru, Rikiya; Ishikura, Satoshi; Ito, Yoshinori; Hiraoka, Masahiro

    2014-05-01

    A domestic multicenter phase I study of stereotactic body radiotherapy (SBRT) for T2N0M0 non-small cell lung cancer in inoperable patients or elderly patients who refused surgery was initiated as the Japan Clinical Oncology Group trial (JCOG0702) in Japan. Prior to the clinical study, the accuracy of dose calculation in radiation treatment-planning systems was surveyed in participating institutions, and differences in the irradiating dose between the institutions were investigated. We developed a water tank-type lung phantom appropriate for verification of the exposure dose in lung SBRT. Using this water tank-type lung phantom, the dose calculated in the radiation treatment-planning system and the measured dose using a free air ionization chamber and dosimetric film were compared in a visiting survey of the seven institutions participating in the clinical study. In all participating institutions, differences between the calculated and the measured dose in the irradiation plan were as follows: the accuracy of the absolute dose in the center of the simulated tumor measured using a free air ionization chamber was within 2%, the mean gamma value was ≤ 0.47 on gamma analysis following the local dose criteria, and the pass rate was >87% for 3%/3 mm from measurement of dose distribution with dosimetric film. These findings confirmed the accuracy of delivery doses in the institutions participating in the clinical study, so that a study with integration of the institutions could be initiated.

  18. Phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy to pelvic lymphadenectomy alone for endometrial cancer: Japan Clinical Oncology Group Study 1412 (SEPAL-P3).

    Science.gov (United States)

    Watari, Hidemichi; Katayama, Hiroshi; Shibata, Taro; Ushijima, Kimio; Satoh, Toyomi; Onda, Takashi; Aoki, Daisuke; Fukuda, Haruhiko; Yaegashi, Nobuo; Sakuragi, Noriaki

    2017-10-01

    To prospectively investigate the survival benefit of para-aortic lymphadenectomy, we launched a new study, the JCOG1412. This is a randomized Phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy to pelvic lymphadenectomy alone. Patients corresponding to possible FIGO Stage IB, II, IIIA, IIIB, and a part of IIIC1 are eligible for the first registration before surgery. Next, those patients without evidence of para-aortic lymph node metastasis and multiple pelvic lymph node metastasis during surgery will be included in the second registration and randomized to either the pelvic lymphadenectomy alone arm or the pelvic and para-aortic lymphadenectomy arm. After the initial surgery, patients with post-operative recurrence risks receive adjuvant chemotherapy. The primary endpoint is overall survival. Secondary endpoints include relapse-free survival, short-term surgical outcomes, adverse events related to adjuvant chemotherapy and recurrence patterns. This trial has been registered at the UMIN Clinical Trials Registry [http://www.umin.ac.jp/ctr/index.htm] as UMIN000025399. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  19. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document

    NARCIS (Netherlands)

    A.P. Kappetein (Arie Pieter); S.J. Head (Stuart); P. Généreux (Philippe); N. Piazza (Nicolo); N.M. van Mieghem (Nicolas); E.H. Blackstone (Eugene); T.G. Brott (Thomas); D.J. Cohen (David J.); D.E. Cutlip (Donald); G.A. van Es (Gerrit Anne); R.T. Hahn (Rebecca); A.J. Kirtane (Ajay); M. Krucoff (Mitchell); S. Kodali (Susheel); M.J. Mack (Michael); R. Mehran (Roxana); J. Rodés-Cabau (Josep); P. Vranckx (Pascal); J.G. Webb (John); S. Windecker (Stephan); P.W.J.C. Serruys (Patrick); M.B. Leon (Martin)

    2012-01-01

    textabstractObjectives: The aim of the current Valvular Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)- clinical endpoints to make them more suitable to the present and future needs of clinical trials. I

  20. Non interventional drug studies in oncology: Why we need them?

    Science.gov (United States)

    Mishra, Divya; Vora, Jesal

    2010-10-01

    Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs). While the randomized nature of the RCT ensures its high internal validity by removing bias, their 'controlled' nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct.

  1. Non interventional drug studies in oncology: Why we need them?

    Directory of Open Access Journals (Sweden)

    Divya Mishra

    2010-01-01

    Full Text Available Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs. While the randomized nature of the RCT ensures its high internal validity by removing bias, their ′controlled′ nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct.

  2. [Strategy for technical evaluation in radiation oncology: methodological and ethical aspects, the French society for radiation oncology's opinion].

    Science.gov (United States)

    Chauvet, B; Mornex, F; Mahé, M-A

    2014-10-01

    Evidence-based medicine is a paradigm founded on a hierarchy of research design, accepted as a dogma. Applied to radiation oncology, and specifically to radiotherapy technical comparisons, evidence-based medicine implies methodological and ethical problems. The concept of "incremental" evolution and the dosimetric evidence are proposed as an acceptable alternative to comparative clinical trials if total dose, time, fractionation, and target volumes are not modified. For other situations, either randomized comparative trials or observational studies are needed. When randomized comparative trials are not possible, observational studies, whose validity can be enhanced by appropriate methodology, must be considered as a valid method. Copyright © 2014 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

  3. Radiation Therapy Oncology Group Protocol 02-29: A Phase II Trial of Neoadjuvant Therapy With Concurrent Chemotherapy and Full-Dose Radiation Therapy Followed by Surgical Resection and Consolidative Therapy for Locally Advanced Non-small Cell Carcinoma of the Lung

    Energy Technology Data Exchange (ETDEWEB)

    Suntharalingam, Mohan, E-mail: msuntha@umm.edu [Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, Maryland (United States); Paulus, Rebecca [Radiation Therapy Oncology Group, Philadelphia, Pennsylvania (United States); Edelman, Martin J. [Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, Maryland (United States); Krasna, Mark [Cancer Center at St. Joseph Medical Center, Towson, Maryland (United States); Burrows, Whitney [Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, Maryland (United States); Gore, Elizabeth [Dept of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Wilson, Lynn D. [Dept of Radiation Oncology, Yale School of Medicine, New Haven, Connecticut (United States); Choy, Hak [Dept of Radiation Oncology, University of Texas Southwestern, Dallas, Texas (United States)

    2012-10-01

    Purpose: To evaluate mediastinal nodal clearance (MNC) rates after induction chemotherapy and concurrent, full-dose radiation therapy (RT) in a phase II trimodality trial (Radiation Therapy Oncology Group protocol 0229). Patients and Methods: Patients (n=57) with stage III non-small cell lung cancer (pathologically proven N2 or N3) were eligible. Induction chemotherapy consisted of weekly carboplatin (AUC = 2.0) and paclitaxel 50 mg/m{sup 2}. Concurrent RT was prescribed, with 50.4 Gy to the mediastinum and primary tumor and a boost of 10.8 Gy to all gross disease. The mediastinum was pathologically reassessed after completion of chemoradiation. The primary endpoint of the study was MNC, with secondary endpoints of 2-year overall survival and postoperative morbidity/mortality. Results: The grade 3/4 toxicities included hematologic 35%, gastrointestinal 14%, and pulmonary 23%. Forty-three patients (75%) were evaluable for the primary endpoint. Twenty-seven patients achieved the primary endpoint of MNC (63%). Thirty-seven patients underwent resection. There was a 14% incidence of grade 3 postoperative pulmonary complications and 1 30-day, postoperative grade 5 toxicity (3%). With a median follow-up of 24 months for all patients, the 2-year overall survival rate was 54%, and the 2-year progression-free survival rate was 33%. The 2-year overall survival rate was 75% for those who achieved nodal clearance, 52% for those with residual nodal disease, and 23% for those who were not evaluable for the primary endpoint (P=.0002). Conclusions: This multi-institutional trial confirms the ability of neoadjuvant concurrent chemoradiation with full-dose RT to sterilize known mediastinal nodal disease.

  4. University of Washington Prostate Cancer Clinical Trials Consortium Application

    Science.gov (United States)

    2011-04-01

    Reported Outcomes John Gore, MD Translational Research (and broccoli !) Joshi Alumkal, MD Protecting Bone for Prostate Cancer Patients Evan...challenge of obtaining metastatic tissues from living patients led to the establishment of  the TAN program at UW.  In addition to the  production  of LuCaP

  5. Overall survival and local recurrence of 406 completely resected stage IIIa-N2 non-small cell lung cancer patients: questionnaire survey of the Japan Clinical Oncology Group to plan for clinical trials.

    Science.gov (United States)

    Ichinose, Y; Kato, H; Koike, T; Tsuchiya, R; Fujisawa, T; Shimizu, N; Watanabe, Y; Mitsudomi, T; Yoshimura, M

    2001-10-01

    the group of completely resected stage IIIA-N2 non-small cell lung cancer patients (NSCLC) is considered to be heterogeneous in various aspects including survival and the recurrent pattern. In the present study, we attempted to clarify the factors which separate these patients into high and low risk groups based on the survival and local recurrence. a questionnaire survey on the survival and local recurrence of non-small cell lung cancer patients with pathological stage IIIA-N2 disease who underwent a complete resection from January 1992 to December 1993 was performed by the Japan Clinical Oncology Group as of July 1999. The information on the survival of 406 patients and that of local recurrence in 332 of them was available. the 5-year survival of the 406 patients was 31.0%. In a univariate analysis, the age, clinical and pathological T status, number of N2 stations, pathological N1 disease, operative modality and postoperative radiotherapy were all found to be important prognostic factors. Clinical N2 disease marginally influenced the survival (P=0.07). In a multivariate analysis of these variables including clinical N2 disease, the survival was significantly worse in the case of multiple N2 stations (hazard ratio=1.741), the presence of pathological N1 disease (1.403), pathological T2 or 3 disease (1.399) and an age older than 65 (1.327). The rate of freedom from any local recurrence at the bronchial stump, or in the hilar, mediastinal or supraclavicular lymph nodes at 5 years was 64%. In a univariate analysis of the freedom from local recurrence, the clinical N status, pathological T status, pathological N1 disease and number of N2 stations were all found to be important prognostic factors. A multivariate analysis revealed the freedom from local recurrence to be adversely influenced by multiple N2 stations (hazard ratio=2.05), and the presence of either clinical N1 or 2 (1.733) disease. The 5-year survival and the rate of freedom from local recurrence at 5

  6. Organisational design for an integrated oncological department

    Directory of Open Access Journals (Sweden)

    Ch.L. Meiss-de Haas

    2001-09-01

    Full Text Available Objective: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated Oncological Department in- and outside (i.e. home care the hospital. Research design: Comparative Qualitative Case Study. Methods: Auditing based on care-as-usual norms by an external, experienced auditing committee. Research setting: Integrated Oncological Departments of three hospitals. Results: Successful multidisciplinary care in an integrated, oncological department needs broad support inside the hospital and a well-defined organisational plan.

  7. Industry progress report on neuro-oncology: a biotech update.

    Science.gov (United States)

    Haber, Jessica S; Banu, Matei A; Ray, Ashley; Kesavabhotla, Kartik; Boockvar, John A

    2013-04-01

    With steadily rising revenue and large numbers of clinical trials utilizing novel treatment strategies, the field of neuro-oncology is at the core of the growing cancer therapy industry. In June 2012, the Weill Cornell Brain and Tumor Center hosted the first Brain Tumor Biotech Summit as a forum for fostering and encouraging collaboration between researches and investors to accelerate novel treatments for brain cancer. This event brought together neuro-oncologists, neurosurgeons, academicians, entrepreneurs, non-profits, CEOs and investors in an attempt to bring innovative treatments and concepts to the fore. Specific subjects presented at the meeting included new surgical devices and delivery techniques, targeted therapeutics, immunotherapy, and stem cell biology. The mission of the summit was to provide opportunities for researchers in neuro-oncology to directly interact with leaders from the investment community with insight into the commercial aspects of our work. Our shared goal is to shorten the time for basic science ideas to be translated into the clinical setting. The following serves as a progress report on the biotech industry in neuro-oncology, as presented at the Brain Tumor Biotech Summit.

  8. 78 FR 25304 - Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), Including On...

    Science.gov (United States)

    2013-04-30

    ... Employment and Training Administration Siemens Medical Solutions, USA, Inc., Oncology Care Systems (Radiation Oncology), Including On-Site Leased Workers From Source Right Solutions, Concord, California, Now Located... 5, 2012, applicable to workers of Siemens Medical Solutions, USA, Inc., Oncology Care...

  9. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the Oncologic Drugs... (FDA). The meeting will be open to the public. Name of Committee: Pediatric Oncology Subcommittee...

  10. Primary Immune Deficiency Treatment Consortium (PIDTC) report

    NARCIS (Netherlands)

    L.M. Griffith (Linda); M. Cowan (Morton); L.D. Notarangelo (Luigi Daniele); R. Kohn (Robert); J. Puck (Jennifer); S.-Y. Pai (Sung-Yun); B. Ballard (Barbara); S.C. Bauer (Sarah); J. Bleesing (Jack); M. Boyle (Marcia); R.W. Brower (Ronald); R.H. Buckley (Rebecca); M. van der Burg (Mirjam); L.M. Burroughs (Lauri); F. Candotti (Fabio); A. Cant (Andrew); T. Chatila (Talal); C. Cunningham-Rundles (Charlotte); M.C. Dinauer (Mary); J. Dvorak (Jennie); A. Filipovich (Alexandra); L.A. Fleisher (Lee); H.B. Gaspar (Bobby); T. Gungor (Tayfun); E. Haddad (Elie); E. Hovermale (Emily); F. Huang (Faith); A. Hurley (Alan); M. Hurley (Mary); S.K. Iyengar (Sudha); E.M. Kang (Elizabeth); B.R. Logan (Brent); J.R. Long-Boyle (Janel); H. Malech (Harry); S.A. McGhee (Sean); S. Modell (Sieglinde); S. Modell (Sieglinde); H.D. Ochs (Hans); R.J. O'Reilly (Richard); R. Parkman (Robertson); D. Rawlings (D.); J.M. Routes (John); P. Shearer (P.); T.N. Small (Trudy); H. Smith (H.); K.E. Sullivan (Kathleen); P. Szabolcs (Paul); A.J. Thrasher (Adrian); D. Torgerson; P. Veys (Paul); K. Weinberg (Kenneth); J.C. Zuniga-Pflucker (Juan Carlos)

    2014-01-01

    textabstractThe Primary Immune Deficiency Treatment Consortium (PIDTC) is a network of 33 centers in North America that study the treatment of rare and severe primary immunodeficiency diseases. Current protocols address the natural history of patients treated for severe combined immunodeficiency (SC

  11. Microbial Degradation of Aniline by Bacterial Consortium

    Institute of Scientific and Technical Information of China (English)

    JIAN-LONG WANG; ZE-YU MAO; WEI-ZHONG WU

    2003-01-01

    Objective To investigate the characteristics of microbial degradation of aniline by a stable bacterial consortium. Methods The bacterial consortium was isolated from activated sludge treating chemical wastewater using aniline as the sole source of carbon and nitrogen by enrichment and isolation technique. The biomass was measured as optical density (OD) at 510 nm using a spectrophotometer. Aniline concentrations were determined by spectrophotometer. The intermediates of aniline degradation were identified by GC/MS method. Results The bacterial consortium could grow at a range of aniline concentrations between 50 and 500 mg/L. The optimal pH and temperature for aniline degradation were determined to be 7.0 and 30, respectively. The presence of NH4NO3 as an additional nitrogen source (100-500 mg/L) had no adverse effect on bacterial growth and aniline degradation. The presence of heavy metal ions, such as Co2+, Zn2+, Ni2+, Mn2+ and Cu2+ had an inhibitory effect on aniline degradation. Conclusions The isolated bacterial consortium candegrade aniline up to 500 mg/L effectively and tolerate some heavy metal ions that commonly exist in chemical wastewater. It has a potential to be applied in the practical treatment of aniline-containingwastewater.

  12. Mission Connect Mild TBI Translational Research Consortium

    Science.gov (United States)

    2010-08-31

    TBI Translational Research Consortium Executive Committee Steering Committee Model of Injury Working Group Neuroprotection Working Group Regeneration ...Report, Holcomb Page 22 Specific aim #3.1: To study neuroprotection and enhanced neurological recovery with erythropoietin ( Epo ) and Epo ...derivatives after MTBI. - #3.1.1 To study the effects of Epo and Epo derivatives on neurogenesis, angiogenesis, and outcome after experimental MTBI

  13. The Digital Preservation Consortium: Mission and Goals.

    Science.gov (United States)

    Walters, Donald J.; Kenney, Anne

    The development of the National Information Infrastructure (NII) and the growing use of the Internet are creating a rapidly-changing environment for collaborative preservation and access. Within this environment, the Digital Preservation Consortium (DPC) seeks to advance the use and utility of digital technology for the preservation of and access…

  14. AMCP Partnership Forum: Driving Value and Outcomes in Oncology.

    Science.gov (United States)

    2017-05-01

    Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself. The Academy of Managed Care Pharmacy (AMCP) convened a Partnership Forum to address how to improve value and outcomes in cancer care. In this multistakeholder forum, several areas were addressed: current methods for assessing the value of oncology products, the need for balancing population management with precision medicine, and the outlook for value-based contracting for oncology medications in managed care settings. Participants recommended ways in which stakeholders can work toward solutions in these areas. The forum brought together stakeholders from health plans, integrated delivery systems, pharmacy benefit managers, clinical practice, biopharmaceutical industry, and laboratory companies. Also participating were representatives from trade and professional associations. During this 1.5-day forum, participants identified current challenges, readiness, and ways to address value and improve outcomes in cancer therapy. Some of the challenges identified include choosing a viable (and practical) outcome target for value-based contracting in oncology, the development and use of value frameworks and clinical pathways, managing cancer diagnostics, utilization of alternative payment systems, moving from a large evidence base to a small clinical trial base in considering targeted treatments, and lack of best practices in value-based payment

  15. Functional MRI and CT biomarkers in oncology

    Energy Technology Data Exchange (ETDEWEB)

    Winfield, J.M. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, CRUK Imaging Centre at the Institute of Cancer Research, Sutton (United Kingdom); Institute of Cancer Research and Royal Marsden Hospital, MRI Unit, Sutton (United Kingdom); Payne, G.S.; DeSouza, N.M. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, CRUK Imaging Centre at the Institute of Cancer Research, Sutton (United Kingdom)

    2015-04-01

    Imaging biomarkers derived from MRI or CT describe functional properties of tumours and normal tissues. They are finding increasing numbers of applications in diagnosis, monitoring of response to treatment and assessment of progression or recurrence. Imaging biomarkers also provide scope for assessment of heterogeneity within and between lesions. A wide variety of functional parameters have been investigated for use as biomarkers in oncology. Some imaging techniques are used routinely in clinical applications while others are currently restricted to clinical trials or preclinical studies. Apparent diffusion coefficient, magnetization transfer ratio and native T{sub 1} relaxation time provide information about structure and organization of tissues. Vascular properties may be described using parameters derived from dynamic contrast-enhanced MRI, dynamic contrast-enhanced CT, transverse relaxation rate (R{sub 2}*), vessel size index and relative blood volume, while magnetic resonance spectroscopy may be used to probe the metabolic profile of tumours. This review describes the mechanisms of contrast underpinning each technique and the technical requirements for robust and reproducible imaging. The current status of each biomarker is described in terms of its validation, qualification and clinical applications, followed by a discussion of the current limitations and future perspectives. (orig.)

  16. A Novel Cross-Disciplinary Multi-Institute Approach to Translational Cancer Research: Lessons Learned from Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC

    Directory of Open Access Journals (Sweden)

    Ashokkumar A. Patel

    2007-01-01

    Full Text Available Background: The Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC, http://www.pcabc.upmc.edu is one of the first major project-based initiatives stemming from the Pennsylvania Cancer Alliance that was funded for four years by the Department of Health of the Commonwealth of Pennsylvania. The objective of this was to initiate a prototype biorepository and bioinformatics infrastructure with a robust data warehouse by developing a statewide data model (1 for bioinformatics and a repository of serum and tissue samples; (2 a data model for biomarker data storage; and (3 a public access website for disseminating research results and bioinformatics tools. The members of the Consortium cooperate closely, exploring the opportunity for sharing clinical, genomic and other bioinformatics data on patient samples in oncology, for the purpose of developing collaborative research programs across cancer research institutions in Pennsylvania. The Consortium’s intention was to establish a virtual repository of many clinical specimens residing in various centers across the state, in order to make them available for research. One of our primary goals was to facilitate the identification of cancer specific biomarkers and encourage collaborative research efforts among the participating centers.Methods: The PCABC has developed unique partnerships so that every region of the state can effectively contribute and participate. It includes over 80 individuals from 14 organizations, and plans to expand to partners outside the State. This has created a network of researchers, clinicians, bioinformaticians, cancer registrars, program directors, and executives from academic and community health systems, as well as external corporate partners - all working together to accomplish a common mission. The various sub-committees have developed a common IRB protocol template, common data elements for standardizing data collections for three organ sites, intellectual

  17. A Novel Cross-Disciplinary Multi-Institute Approach to Translational Cancer Research: Lessons Learned from Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC)

    Science.gov (United States)

    Patel, Ashokkumar A.; Gilbertson, John R.; Showe, Louise C.; London, Jack W.; Ross, Eric; Ochs, Michael F.; Carver, Joseph; Lazarus, Andrea; Parwani, Anil V.; Dhir, Rajiv; Beck, J. Robert; Liebman, Michael; Garcia, Fernando U.; Prichard, Jeff; Wilkerson, Myra; Herberman, Ronald B.; Becich, Michael J.

    2007-01-01

    Background: The Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC, http://www.pcabc.upmc.edu) is one of the first major project-based initiatives stemming from the Pennsylvania Cancer Alliance that was funded for four years by the Department of Health of the Commonwealth of Pennsylvania. The objective of this was to initiate a prototype biorepository and bioinformatics infrastructure with a robust data warehouse by developing a statewide data model (1) for bioinformatics and a repository of serum and tissue samples; (2) a data model for biomarker data storage; and (3) a public access website for disseminating research results and bioinformatics tools. The members of the Consortium cooperate closely, exploring the opportunity for sharing clinical, genomic and other bioinformatics data on patient samples in oncology, for the purpose of developing collaborative research programs across cancer research institutions in Pennsylvania. The Consortium’s intention was to establish a virtual repository of many clinical specimens residing in various centers across the state, in order to make them available for research. One of our primary goals was to facilitate the identification of cancer-specific biomarkers and encourage collaborative research efforts among the participating centers. Methods: The PCABC has developed unique partnerships so that every region of the state can effectively contribute and participate. It includes over 80 individuals from 14 organizations, and plans to expand to partners outside the State. This has created a network of researchers, clinicians, bioinformaticians, cancer registrars, program directors, and executives from academic and community health systems, as well as external corporate partners - all working together to accomplish a common mission. The various sub-committees have developed a common IRB protocol template, common data elements for standardizing data collections for three organ sites, intellectual property

  18. Biological and clinical evaluation of lanreotide (BIM 23014), a somatostatin analogue, in the treatment of advanced breast cancer. A pilot study by the I.T.M.O. Group. Italian Trials in Medical Oncology.

    Science.gov (United States)

    Di Leo, A; Ferrari, L; Bajetta, E; Bartoli, C; Vicario, G; Moglia, D; Miceli, R; Callegari, M; Bono, A

    1995-06-01

    Biological data support the development of clinical trials designed to evaluate the activity of somatostatin (SMS) analogues in advanced breast cancer (ABC). Although previous clinical trials have failed to show antitumor activity, various factors may have biased their results. In an attempt to improve our understanding of the role of SMS analogues in ABC, 10 patients with favourable prognostic factors and who had not been heavily pretreated for advanced disease were treated with lanreotide 30 mg i.m. fortnightly (depot formulation). Blood samples were periodically taken to evaluate the effect of the drug on growth hormone (GH) and insulin-like growth factor 1 (IGF-1) and to determine drug serum levels. Although the drug was well tolerated, no clinical activity was observed. Serum GH and IGF-1 levels were not properly suppressed over time and drug serum concentrations fluctuated widely. In conclusion, SMS analogues cannot be recommended even as palliative treatment of ABC. Further studies should be undertaken to investigate the effect of higher drug doses, given subcutaneously or by means of continuous infusion, in suppressing GH and IGF-1 serum levels.

  19. Ophthalmic epidemiology in Europe: the "European Eye Epidemiology" (E3) consortium.

    Science.gov (United States)

    Delcourt, Cécile; Korobelnik, Jean-François; Buitendijk, Gabriëlle H S; Foster, Paul J; Hammond, Christopher J; Piermarocchi, Stefano; Peto, Tunde; Jansonius, Nomdo; Mirshahi, Alireza; Hogg, Ruth E; Bretillon, Lionel; Topouzis, Fotis; Deak, Gabor; Grauslund, Jakob; Broe, Rebecca; Souied, Eric H; Creuzot-Garcher, Catherine; Sahel, José; Daien, Vincent; Lehtimäki, Terho; Hense, Hans-Werner; Prokofyeva, Elena; Oexle, Konrad; Rahi, Jugnoo S; Cumberland, Phillippa M; Schmitz-Valckenberg, Steffen; Fauser, Sascha; Bertelsen, Geir; Hoyng, Carel; Bergen, Arthur; Silva, Rufino; Wolf, Sebastian; Lotery, Andrew; Chakravarthy, Usha; Fletcher, Astrid; Klaver, Caroline C W

    2016-02-01

    The European Eye Epidemiology (E3) consortium is a recently formed consortium of 29 groups from 12 European countries. It already comprises 21 population-based studies and 20 other studies (case-control, cases only, randomized trials), providing ophthalmological data on approximately 170,000 European participants. The aim of the consortium is to promote and sustain collaboration and sharing of data and knowledge in the field of ophthalmic epidemiology in Europe, with particular focus on the harmonization of methods for future research, estimation and projection of frequency and impact of visual outcomes in European populations (including temporal trends and European subregions), identification of risk factors and pathways for eye diseases (lifestyle, vascular and metabolic factors, genetics, epigenetics and biomarkers) and development and validation of prediction models for eye diseases. Coordinating these existing data will allow a detailed study of the risk factors and consequences of eye diseases and visual impairment, including study of international geographical variation which is not possible in individual studies. It is expected that collaborative work on these existing data will provide additional knowledge, despite the fact that the risk factors and the methods for collecting them differ somewhat among the participating studies. Most studies also include biobanks of various biological samples, which will enable identification of biomarkers to detect and predict occurrence and progression of eye diseases. This article outlines the rationale of the consortium, its design and presents a summary of the methodology.

  20. Introduction to veterinary clinical oncology

    Energy Technology Data Exchange (ETDEWEB)

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  1. Introduction to veterinary clinical oncology

    Energy Technology Data Exchange (ETDEWEB)

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  2. New Technologies in Radiation Oncology

    Science.gov (United States)

    Schlegel, Wolfgang; Bortfeld, Thomas; Grosu, Anca-Ligia

    This book provides an overview of recent advances in radiation oncology, many of which have originated from physics and engineering sciences. After an introductory section on basic aspects of 3D medical imaging, the role of 3D imaging in the context of radiotherapy is explored in a series of chapters on the various modern imaging techniques. A further major section addresses 3D treatment planning for conformal radiotherapy, with consideration of both external radiotherapy and brachytherapy. Subsequently the modern techniques of 3D conformal radiotherapy are described, including stereotactic radiotherapy, intensity-modulated radiation therapy, image-guided and adaptive radiotherapy, and radiotherapy with charged particles.

  3. A randomized phase III trial of adjuvant chemotherapy with irinotecan, leucovorin and fluorouracil versus leucovorin and fluorouracil for stage II and III colon cancer: A Hellenic Cooperative Oncology Group study

    Directory of Open Access Journals (Sweden)

    Efstratiou Ioannis

    2011-01-01

    Full Text Available Abstract Background Colon cancer is a public health problem worldwide. Adjuvant chemotherapy after surgical resection for stage III colon cancer has been shown to improve both progression-free and overall survival, and is currently recommended as standard therapy. However, its value for patients with stage II disease remains controversial. When this study was designed 5-fluorouracil (5FU plus leucovorin (LV was standard adjuvant treatment for colon cancer. Irinotecan (CPT-11 is a topoisomerase I inhibitor with activity in metastatic disease. In this multicenter adjuvant phase III trial, we evaluated the addition of irinotecan to weekly 5FU plus LV in patients with stage II or III colon cancer. Methods The study included 873 eligible patients. The treatment consisted of weekly administration of irinotecan 80 mg/m2 intravenously (IV, LV 200 mg/m2 and 5FU 450 mg/m2 bolus (Arm A versus LV 200 mg/m2 and 5FU 500 mg/m2 IV bolus (Arm B. In Arm A, treatments were administered weekly for four consecutive weeks, followed by a two-week rest, for a total of six cycles, while in Arm B treatments were administered weekly for six consecutive weeks, followed by a two-week rest, for a total of four cycles. The primary end-point was disease-free survival (DFS at three years. Results The probability of overall survival (OS at three years was 0.88 for patients in Arm A and 0.86 for those in Arm B, while the five-year OS probability was 0.78 and 0.76 for patients in Arm A and Arm B, respectively (P = 0.436. Furthermore, the probability of DFS at three years was 0.78 and 0.76 for patients in Arm A and Arm B, respectively (P = 0.334. With the exception of leucopenia and neutropenia, which were higher in patients in Arm A, there were no significant differences in Grades 3 and 4 toxicities between the two regimens. The most frequently recorded Grade 3/4 toxicity was diarrhea in both treatment arms. Conclusions Irinotecan added to weekly bolus 5FU plus LV did not result

  4. Crowdfunding drug development: the state of play in oncology and rare diseases.

    Science.gov (United States)

    Dragojlovic, Nick; Lynd, Larry D

    2014-11-01

    In this article, we present descriptive data on 125 crowdfunding campaigns aimed at financing research in oncology (including basic research, drug discovery, and clinical trials). We also describe five campaigns that have succeeded in raising substantial funds to support the development of treatments for ultrarare diseases. The data suggest that crowdfunding is a viable approach to supporting early proof-of-concept research that could allow researchers in oncology and rare diseases to succeed in traditional grant competitions or to attract private investment. The data also suggest that such an approach could become a valuable additional source of funding for early-stage innovators in the drug development arena.

  5. Rapamycin pharmacokinetic and pharmacodynamic relationships in osteosarcoma: a comparative oncology study in dogs.

    Directory of Open Access Journals (Sweden)

    Melissa C Paoloni

    Full Text Available BACKGROUND: Signaling through the mTOR pathway contributes to growth, progression and chemoresistance of several cancers. Accordingly, inhibitors have been developed as potentially valuable therapeutics. Their optimal development requires consideration of dose, regimen, biomarkers and a rationale for their use in combination with other agents. Using the infrastructure of the Comparative Oncology Trials Consortium many of these complex questions were asked within a relevant population of dogs with osteosarcoma to inform the development of mTOR inhibitors for future use in pediatric osteosarcoma patients. METHODOLOGY/PRINCIPAL FINDINGS: This prospective dose escalation study of a parenteral formulation of rapamycin sought to define a safe, pharmacokinetically relevant, and pharmacodynamically active dose of rapamycin in dogs with appendicular osteosarcoma. Dogs entered into dose cohorts consisting of 3 dogs/cohort. Dogs underwent a pre-treatment tumor biopsy and collection of baseline PBMC. Dogs received a single intramuscular dose of rapamycin and underwent 48-hour whole blood pharmacokinetic sampling. Additionally, daily intramuscular doses of rapamycin were administered for 7 days with blood rapamycin trough levels collected on Day 8, 9 and 15. At Day 8 post-treatment collection of tumor and PBMC were obtained. No maximally tolerated dose of rapamycin was attained through escalation to the maximal planned dose of 0.08 mg/kg (2.5 mg/30 kg dog. Pharmacokinetic analysis revealed a dose-dependent exposure. In all cohorts modulation of the mTOR pathway in tumor and PBMC (pS6RP/S6RP was demonstrated. No change in pAKT/AKT was seen in tumor samples following rapamycin therapy. CONCLUSIONS/SIGNIFICANCE: Rapamycin may be safely administered to dogs and can yield therapeutic exposures. Modulation pS6RP/S6RP in tumor tissue and PBMCs was not dependent on dose. Results from this study confirm that the dog may be included in the translational development of

  6. Report from the OECI Oncology Days 2014

    NARCIS (Netherlands)

    Harten, van W.H.; Stanta, G.; Bussolati, G.; Riegman, P.; Hoefler, G.; Becker, K.F.; Folprecht, G.; Truini, M.; Haybaeck, J.; Buiga, R.; Dono, M.; Bagg, A.; Lopez Guerrero, J.A.; Zupo, S.; Lemare, F.; Lorenzo, de F.; Goedbloed, N.; Razavi, D.; Lovey, J.; Cadariu, P.A.; Rollandi, G.A.; Paparo, F.; Pierotti, M.; Ciuleanu, T.; de Paoli, P.; Weiner, G.; Saghatchian, M.; Lombardo, Claudio

    2014-01-01

    The 2014 OECI Oncology Days was held at the ‘Prof. Dr. Ion Chiricuta’ Oncology Institute in Cluj, Romania, from 12 to 13 June. The focus of this year’s gathering was on developments in personalised medicine and other treatment advances which have made the cost of cancer care too high for many region

  7. Nursing 436A: Pediatric Oncology for Nurses.

    Science.gov (United States)

    Jackman, Cynthia L.

    A description is provided of "Pediatric Oncology for Nurses," the first in a series of three courses offered to fourth-year nursing students in pediatric oncology. The first section provides a course overview, discusses time assignments, and describes the target student population. Next, a glossary of terms, and lists of course goals, long-range…

  8. Perceptions of Oncology as a Medical Specialty.

    Science.gov (United States)

    Cassileth, Barrie R.; And Others

    1980-01-01

    The characteristics and prestige associated with oncology and assessed shifts in medical students' perceptions as a result of participation in an oncology course are explored. Respondents were asked to rate the prestige of eight specialities and asked to select characteristics "that best describe each type of specialist." (MLW)

  9. Art Therapy with an Oncology Care Team

    Science.gov (United States)

    Nainis, Nancy A.

    2005-01-01

    Oncology nurses are particularly vulnerable to "burnout" syndrome due to the intensity of their work and the ongoing losses they experience while providing oncology care to their patients. High levels of stress in the workplace left untended lead to high job turnover, poor productivity, and diminished quality of care for patients.…

  10. Clinical Oncology Assistantship Program for Medical Students.

    Science.gov (United States)

    Neilan, Barbara A.; And Others

    1985-01-01

    The Clinical Oncology Assistantship Program at the University of Arkansas for Medical Sciences is described, along with student reactions to the program. The summer elective program involves cancer lectures (one week) and clinical exposure (nine weeks) in medical, surgical, and pediatric oncology services, as well as self-directed learning…

  11. Organisational design for an integrated oncological department

    NARCIS (Netherlands)

    Meiss-de Haas, Ch.L.; Falkmann, H.; Douma, J.; Van Gassel, J.G.; Peters, W.G.; Van Mierlo, R.; Van Turnhout, J.M.; Verhagen, C.A.H.H.V.M.; Schrijvers, A.J.P.

    2001-01-01

    Objective: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT) analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated Oncolog

  12. Oncologic Outcomes After Transoral Robotic Surgery

    Science.gov (United States)

    Magnuson, J. Scott; Smith, Richard V.; Moore, Eric; Lawson, Georges; Remacle, Marc; Ganly, Ian; Kraus, Dennis H.; Teng, Marita S.; Miles, Brett A.; White, Hilliary; Duvvuri, Umamaheswar; Ferris, Robert L.; Mehta, Vikas; Kiyosaki, Krista; Damrose, Edward J.; Wang, Steven J.; Kupferman, Michael E.; Koh, Yoon Woo; Genden, Eric M.; Holsinger, F. Christopher

    2016-01-01

    all-cause mortality (P = .01). Although advanced age and tobacco use were associated with locoregional recurrence and disease-specific survival, they, as well as tumor stage and other adverse histopathologic features, did not remain significant on multivariate analysis. CONCLUSIONS AND RELEVANCE This large, multi-institutional study supports the role of TORS within the multidisciplinary treatment paradigm for the treatment of head and neck cancer, especially for patients with oropharyngeal cancer. Favorable oncologic outcomes have been found across institutions. Ongoing comparative clinical trials funded by the National Cancer Institute will further evaluate the role of robotic surgery for patients with head and neck cancers. PMID:26402479

  13. Big data in oncologic imaging.

    Science.gov (United States)

    Regge, Daniele; Mazzetti, Simone; Giannini, Valentina; Bracco, Christian; Stasi, Michele

    2017-06-01

    Cancer is a complex disease and unfortunately understanding how the components of the cancer system work does not help understand the behavior of the system as a whole. In the words of the Greek philosopher Aristotle "the whole is greater than the sum of parts." To date, thanks to improved information technology infrastructures, it is possible to store data from each single cancer patient, including clinical data, medical images, laboratory tests, and pathological and genomic information. Indeed, medical archive storage constitutes approximately one-third of total global storage demand and a large part of the data are in the form of medical images. The opportunity is now to draw insight on the whole to the benefit of each individual patient. In the oncologic patient, big data analysis is at the beginning but several useful applications can be envisaged including development of imaging biomarkers to predict disease outcome, assessing the risk of X-ray dose exposure or of renal damage following the administration of contrast agents, and tracking and optimizing patient workflow. The aim of this review is to present current evidence of how big data derived from medical images may impact on the diagnostic pathway of the oncologic patient.

  14. [Therapeutic Aggressiveness and Liquid Oncology].

    Science.gov (United States)

    Barón Duarte, F J; Rodríguez Calvo, M S; Amor Pan, J R

    2017-01-01

    Aggressiveness criteria proposed in the scientific literature a decade ago provide a quality judgment and are a reference in the care of patients with advanced cancer, but their use is not generalized in the evaluation of Oncology Services. In this paper we analyze the therapeutic aggressiveness, according to standard criteria, in 1.001 patients with advanced cancer who died in our Institution between 2010 and 2013. The results seem to show that aggressiveness at the end of life is present more frequently than experts recommend. About 25% of patients fulfill at least one criterion of aggressiveness. This result could be explained by a liquid Oncology which does not prioritize the patient as a moral subject in the clinical appointment. Medical care is oriented to necessities and must be articulated in a model focused on dignity and communication. Its implementation through Advanced Care Planning, consideration of patient's values and preferences, and Limitation of therapeutic effort are ways to reduce aggressiveness and improve clinical practice at the end of life. We need to encourage synergic and proactive attitudes, adding the best of cancer research with the best clinical care for the benefit of human being, moral subject and main goal of Medicine.

  15. Decision making in surgical oncology.

    Science.gov (United States)

    Lamb, B; Green, J S A; Vincent, C; Sevdalis, N

    2011-09-01

    Decisions in surgical oncology are increasingly being made by multi-disciplinary teams (MDTs). Although MDTs have been widely accepted as the preferred model for cancer service delivery, the process of decision making has not been well described and there is little evidence pointing to the ideal structure of an MDT. Performance in surgery has been shown to depend on non-technical skills, such as decision making, as well as patient factors and the technical skills of the healthcare team. Application of this systems approach to MDT working allows the identification of factors that affect the quality of decision making for cancer patients. In this article we review the literature on decision making in surgical oncology and by drawing from the systems approach to surgical performance we provide a framework for understanding the process of decision making in MDTs. Technical factors that affect decision making include the information about patients, robust ICT and video-conferencing equipment, a minimum dataset with expert review of radiological and pathological information, implementation and recording of the MDTs decision. Non-technical factors with an impact on decision making include attendance of team members at meetings, leadership, teamwork, open discussion, consensus on decisions and communication with patients and primary care. Optimising these factors will strengthen the decision making process and raise the quality of care for cancer patients.

  16. Optical imaging probes in oncology.

    Science.gov (United States)

    Martelli, Cristina; Lo Dico, Alessia; Diceglie, Cecilia; Lucignani, Giovanni; Ottobrini, Luisa

    2016-07-26

    Cancer is a complex disease, characterized by alteration of different physiological molecular processes and cellular features. Keeping this in mind, the possibility of early identification and detection of specific tumor biomarkers by non-invasive approaches could improve early diagnosis and patient management.Different molecular imaging procedures provide powerful tools for detection and non-invasive characterization of oncological lesions. Clinical studies are mainly based on the use of computed tomography, nuclear-based imaging techniques and magnetic resonance imaging. Preclinical imaging in small animal models entails the use of dedicated instruments, and beyond the already cited imaging techniques, it includes also optical imaging studies. Optical imaging strategies are based on the use of luminescent or fluorescent reporter genes or injectable fluorescent or luminescent probes that provide the possibility to study tumor features even by means of fluorescence and luminescence imaging. Currently, most of these probes are used only in animal models, but the possibility of applying some of them also in the clinics is under evaluation.The importance of tumor imaging, the ease of use of optical imaging instruments, the commercial availability of a wide range of probes as well as the continuous description of newly developed probes, demonstrate the significance of these applications. The aim of this review is providing a complete description of the possible optical imaging procedures available for the non-invasive assessment of tumor features in oncological murine models. In particular, the characteristics of both commercially available and newly developed probes will be outlined and discussed.

  17. Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews.

    Science.gov (United States)

    Chan, John K; Kiet, Tuyen K; Monk, Bradley J; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S; Amanam, Idoroenyi

    2014-03-01

    Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. All applications referred to the ODAC from 2001 to 2012 were reviewed. Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001-2004, 2005-2008, 2009-2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs.

  18. Applications for Oncologic Drugs: A Descriptive Analysis of the Oncologic Drugs Advisory Committee Reviews

    Science.gov (United States)

    Kiet, Tuyen K.; Monk, Bradley J.; Young-Lin, Nichole; Blansit, Kevin; Kapp, Daniel S.; Amanam, Idoroenyi

    2014-01-01

    Background Despite advances in cancer research, the majority of drug applications submitted to the U.S. Food and Drug Administration (FDA) are not approved. It is important to identify the concerns of the Oncologic Drugs Advisory Committee (ODAC) from rejected applications. Methods All applications referred to the ODAC from 2001 to 2012 were reviewed. Results Of 46 applications, 31 (67%) were for full and 15 (33%) were for supplemental approval, 34 (74%) were for solid and 12 (26%) were for hematologic tumors. In all, 22 (48%) were not approved. ODAC comments addressed missing or inadequate data (65%), excessive toxicity (55%), inappropriate study endpoints (45%), poor study design (40%), and insufficient sample size (30%). To define efficacy, 19 applications used response rates (RR) (median = 38%), and 19 applications used hazard ratios (HR) (median = 0.67). For all organ systems combined, the median cumulative grade 3 or 4 toxicity was 64%. Drugs with higher RR, lower HR, and lower toxicity were more likely to be approved versus other drugs (89% vs. 45%; p = .02). Over time (2001–2004, 2005–2008, 2009–2012), there was an increase in the following: number of applications submitted for review (from 11 to 12 to 23, respectively), number of approvals (from 6 to 6 to 12, respectively), and proportion of trials using progression-free survival as a primary endpoint (from 0% to 50% to 70%, respectively; p = .01). Conclusion. Of all applications, common ODAC concerns included inadequate data, excessive toxicity, and inappropriate study endpoints. Over time, there was an approximate doubling of FDA application submissions and approved oncology drugs. PMID:24599479

  19. Seeking genetic susceptibility variants for colorectal cancer: the EPICOLON consortium experience.

    Science.gov (United States)

    Castellví-Bel, Sergi; Ruiz-Ponte, Clara; Fernández-Rozadilla, Ceres; Abulí, Anna; Muñoz, Jenifer; Bessa, Xavier; Brea-Fernández, Alejandro; Ferro, Marta; Giráldez, María Dolores; Xicola, Rosa M; Llor, Xavier; Jover, Rodrigo; Piqué, Josep M; Andreu, Montserrat; Castells, Antoni; Carracedo, Angel

    2012-03-01

    The EPICOLON consortium was initiated in 1999 by the Gastrointestinal Oncology Group of the Spanish Gastroenterology Association. It recruited consecutive, unselected, population-based colorectal cancer (CRC) cases and control subjects matched by age and gender without personal or familial history of cancer all over Spain with the main goal of gaining knowledge in Lynch syndrome and familial CRC. This epidemiological, prospective and multicentre study collected extensive clinical data and biological samples from ∼2000 CRC cases and 2000 controls in Phases 1 and 2 involving 25 and 14 participating hospitals, respectively. Genetic susceptibility projects in EPICOLON have included candidate-gene approaches evaluating single-nucleotide polymorphisms/genes from the historical category (linked to CRC risk by previous studies), from human syntenic CRC susceptibility regions identified in mouse, from the CRC carcinogenesis-related pathways Wnt and BMP, from regions 9q22 and 3q22 with positive linkage in CRC families, and from the mucin gene family. This consortium has also participated actively in the identification 5 of the 16 common, low-penetrance CRC genetic variants identified so far by genome-wide association studies. Finishing their own pangenomic study and performing whole-exome sequencing in selected CRC samples are among EPICOLON future research prospects.

  20. Consortium for Verification Technology Fellowship Report.

    Energy Technology Data Exchange (ETDEWEB)

    Sadler, Lorraine E. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-06-01

    As one recipient of the Consortium for Verification Technology (CVT) Fellowship, I spent eight days as a visiting scientist at the University of Michigan, Department of Nuclear Engineering and Radiological Sciences (NERS). During this time, I participated in multiple department and research group meetings and presentations, met with individual faculty and students, toured multiple laboratories, and taught one-half of a one-unit class on Risk Analysis in Nuclear Arms control (six 1.5 hour lectures). The following report describes some of the interactions that I had during my time as well as a brief discussion of the impact of this fellowship on members of the consortium and on me/my laboratory’s technical knowledge and network.

  1. The NIH Extracellular RNA Communication Consortium.

    Science.gov (United States)

    Ainsztein, Alexandra M; Brooks, Philip J; Dugan, Vivien G; Ganguly, Aniruddha; Guo, Max; Howcroft, T Kevin; Kelley, Christine A; Kuo, Lillian S; Labosky, Patricia A; Lenzi, Rebecca; McKie, George A; Mohla, Suresh; Procaccini, Dena; Reilly, Matthew; Satterlee, John S; Srinivas, Pothur R; Church, Elizabeth Stansell; Sutherland, Margaret; Tagle, Danilo A; Tucker, Jessica M; Venkatachalam, Sundar

    2015-01-01

    The Extracellular RNA (exRNA) Communication Consortium, funded as an initiative of the NIH Common Fund, represents a consortium of investigators assembled to address the critical issues in the exRNA research arena. The overarching goal is to generate a multi-component community resource for sharing fundamental scientific discoveries, protocols, and innovative tools and technologies. The key initiatives include (a) generating a reference catalogue of exRNAs present in body fluids of normal healthy individuals that would facilitate disease diagnosis and therapies, (b) defining the fundamental principles of exRNA biogenesis, distribution, uptake, and function, as well as development of molecular tools, technologies, and imaging modalities to enable these studies,

  2. Overview of the Inland California Translational Consortium

    Science.gov (United States)

    Malkas, Linda H.

    2017-05-01

    The mission of the Inland California Translational Consortium (ICTC), an independent research consortium comprising a unique hub of regional institutions (City of Hope [COH], California Institute of Technology [Caltech], Jet Propulsion Laboratory [JPL], University of California Riverside [UCR], and Claremont Colleges Keck Graduate Institute [KGI], is to institute a new paradigm within the academic culture to accelerate translation of innovative biomedical discoveries into clinical applications that positively affect human health and life. The ICTC actively supports clinical translational research as well as the implementation and advancement of novel education and training models for the translation of basic discoveries into workable products and practices that preserve and improve human health while training and educating at all levels of the workforce using innovative forward-thinking approaches.

  3. Midwest Nuclear Science and Engineering Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Dr. Wynn Volkert; Dr. Arvind Kumar; Dr. Bryan Becker; Dr. Victor Schwinke; Dr. Angel Gonzalez; Dr. DOuglas McGregor

    2010-12-08

    The objective of the Midwest Nuclear Science and Engineering Consortium (MNSEC) is to enhance the scope, quality and integration of educational and research capabilities of nuclear sciences and engineering (NS/E) programs at partner schools in support of the U.S. nuclear industry (including DOE laboratories). With INIE support, MNSEC had a productive seven years and made impressive progress in achieving these goals. Since the past three years have been no-cost-extension periods, limited -- but notable -- progress has been made in FY10. Existing programs continue to be strengthened and broadened at Consortium partner institutions. The enthusiasm generated by the academic, state, federal, and industrial communities for the MNSEC activities is reflected in the significant leveraging that has occurred for our programs.

  4. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    Science.gov (United States)

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2016-03-01

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.

  5. The STRONG STAR Multidisciplinary PTSD Research Consortium

    Science.gov (United States)

    2013-09-01

    myocardial infarction and pre- dicting variables. J. Psychosom. Res. 69, 143e150. Harvey, B.H., Brand, L., Jeeva, Z., Stein, D.J., 2006. Cortical...For the STRONG STAR Consortium. Available online at www.sciencedirect.com j our na l h omepa g e: www.e l se v ie r.c om /l oca te/ psyne ue n 0306

  6. Massachusetts Institute of Technology Consortium Agreement

    Science.gov (United States)

    1999-03-01

    This is the third progress report of the M.I.T. Home Automation and Healthcare Consortium-Phase Two. It covers majority of the new findings, concepts...research projects of home automation and healthcare, ranging from human modeling, patient monitoring, and diagnosis to new sensors and actuators, physical...aids, human-machine interface and home automation infrastructure. This report contains several patentable concepts, algorithms, and designs.

  7. Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG Study

    Directory of Open Access Journals (Sweden)

    Arie Figer, Aviram Nissan, Adi Shani, Riva Borovick, Mariana Stiener, Mario Baras, Herbert R. Freund, Aaron Sulkes, Alexander Stojadinovic, Tamar Peretz

    2011-01-01

    Full Text Available Objective: Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC. This study evaluates long-term (10-year outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV or 5-FU/Levamisole (5FU+LEV.Methods: Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months.Results: No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02 and gastrointestinal toxicity with 5FU+LV (p=0.03. Female patients treated with 5FU+LEV had improved overall survival.Conclusions: Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset.

  8. Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG) Study

    Science.gov (United States)

    Figer, Arie; Nissan, Aviram; Shani, Adi; Borovick, Riva; Stiener, Mariana; Baras, Mario; Freund, Herbert R.; Sulkes, Aaron; Stojadinovic, Alexander; Peretz, Tamar

    2011-01-01

    Objective: Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC). This study evaluates long-term (10-year) outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV) or 5-FU/Levamisole (5FU+LEV). Methods: Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months. Results: No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02) and gastrointestinal toxicity with 5FU+LV (p=0.03). Female patients treated with 5FU+LEV had improved overall survival. Conclusions: Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset. PMID:21475636

  9. A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC): Japan Clinical Oncology Group Study JCOG1017.

    Science.gov (United States)

    Shien, Tadahiko; Nakamura, Kenichi; Shibata, Taro; Kinoshita, Takayuki; Aogi, Kenjiro; Fujisawa, Tomomi; Masuda, Norikazu; Inoue, Kenichi; Fukuda, Haruhiko; Iwata, Hiroji

    2012-10-01

    This trial is being conducted to confirm the superiority, in terms of overall survival, of primary tumour resection plus systemic therapy to systemic therapy alone in patients with Stage IV breast cancer who are not refractory to primary systemic therapy. The inclusion criteria for the study are as follows: untreated patients with histologically confirmed invasive breast cancer with one or more measurable metastatic lesions diagnosed by radiological examination. All patients receive primary systemic therapy according to the estrogen receptor and human epidermal growth factor receptor type-2 status of the primary breast cancer after the first registration. After 3 months, the patients without disease progression are randomized to the primary tumour resection plus systemic therapy arm or the systemic therapy alone arm. The primary endpoint is the overall survival, and the secondary endpoints are proportion of patients without tumour progression at the metastatic sites, yearly local recurrence-free survival, proportion of local ulcer/local bleeding, yearly primary tumour resection-free survival, adverse events of chemotherapy, operative morbidity and serious adverse events. The patient recruitment was commenced in May 2011. Enrolment of 410 patients for randomization is planned over a 5 year recruitment period. We hereby report the details of the study.

  10. Removal of triphenylmethane dyes by bacterial consortium.

    Science.gov (United States)

    Cheriaa, Jihane; Khaireddine, Monia; Rouabhia, Mahmoud; Bakhrouf, Amina

    2012-01-01

    A new consortium of four bacterial isolates (Agrobacterium radiobacter; Bacillus spp.; Sphingomonas paucimobilis, and Aeromonas hydrophila)-(CM-4) was used to degrade and to decolorize triphenylmethane dyes. All bacteria were isolated from activated sludge extracted from a wastewater treatment station of a dyeing industry plant. Individual bacterial isolates exhibited a remarkable color-removal capability against crystal violet (50 mg/L) and malachite green (50 mg/L) dyes within 24 h. Interestingly, the microbial consortium CM-4 shows a high decolorizing percentage for crystal violet and malachite green, respectively, 91% and 99% within 2 h. The rate of chemical oxygen demand (COD) removal increases after 24 h, reaching 61.5% and 84.2% for crystal violet and malachite green, respectively. UV-Visible absorption spectra, FTIR analysis and the inspection of bacterial cells growth indicated that color removal by the CM-4 was due to biodegradation. Evaluation of mutagenicity by using Salmonella typhimurium test strains, TA98 and TA100 studies revealed that the degradation of crystal violet and malachite green by CM-4 did not lead to mutagenic products. Altogether, these results demonstrated the usefulness of the bacterial consortium in the treatment of the textile dyes.

  11. Primary Immune Deficiency Treatment Consortium (PIDTC) report.

    Science.gov (United States)

    Griffith, Linda M; Cowan, Morton J; Notarangelo, Luigi D; Kohn, Donald B; Puck, Jennifer M; Pai, Sung-Yun; Ballard, Barbara; Bauer, Sarah C; Bleesing, Jack J H; Boyle, Marcia; Brower, Amy; Buckley, Rebecca H; van der Burg, Mirjam; Burroughs, Lauri M; Candotti, Fabio; Cant, Andrew J; Chatila, Talal; Cunningham-Rundles, Charlotte; Dinauer, Mary C; Dvorak, Christopher C; Filipovich, Alexandra H; Fleisher, Thomas A; Bobby Gaspar, Hubert; Gungor, Tayfun; Haddad, Elie; Hovermale, Emily; Huang, Faith; Hurley, Alan; Hurley, Mary; Iyengar, Sumathi; Kang, Elizabeth M; Logan, Brent R; Long-Boyle, Janel R; Malech, Harry L; McGhee, Sean A; Modell, Fred; Modell, Vicki; Ochs, Hans D; O'Reilly, Richard J; Parkman, Robertson; Rawlings, David J; Routes, John M; Shearer, William T; Small, Trudy N; Smith, Heather; Sullivan, Kathleen E; Szabolcs, Paul; Thrasher, Adrian; Torgerson, Troy R; Veys, Paul; Weinberg, Kenneth; Zuniga-Pflucker, Juan Carlos

    2014-02-01

    The Primary Immune Deficiency Treatment Consortium (PIDTC) is a network of 33 centers in North America that study the treatment of rare and severe primary immunodeficiency diseases. Current protocols address the natural history of patients treated for severe combined immunodeficiency (SCID), Wiskott-Aldrich syndrome, and chronic granulomatous disease through retrospective, prospective, and cross-sectional studies. The PIDTC additionally seeks to encourage training of junior investigators, establish partnerships with European and other International colleagues, work with patient advocacy groups to promote community awareness, and conduct pilot demonstration projects. Future goals include the conduct of prospective treatment studies to determine optimal therapies for primary immunodeficiency diseases. To date, the PIDTC has funded 2 pilot projects: newborn screening for SCID in Navajo Native Americans and B-cell reconstitution in patients with SCID after hematopoietic stem cell transplantation. Ten junior investigators have received grant awards. The PIDTC Annual Scientific Workshop has brought together consortium members, outside speakers, patient advocacy groups, and young investigators and trainees to report progress of the protocols and discuss common interests and goals, including new scientific developments and future directions of clinical research. Here we report the progress of the PIDTC to date, highlights of the first 2 PIDTC workshops, and consideration of future consortium objectives.

  12. Midwest superconductivity consortium. 1993 Progress report

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    The Midwest Superconductivity Consortium, MISCON, in the fourth year of operations further strengthened its mission to advance the science and understanding of high T{sub c} superconductivity. The goals of the organization and the individual projects continue to reflect the current needs for new knowledge in the field and the unique capabilities of the institutions involved. Group efforts and cooperative laboratory interactions to achieve the greatest possible synergy under the Consortium continue to be emphasized. Industrial affiliations coupled with technology transfer initiatives were expanded. Activities of the participants during the past year achieved an interactive and high level of performance. The number of notable achievements in the field contributed by Consortium investigators increased. The programmatic research continues to focus upon key materials-related problems in two areas. The first area has a focus upon {open_quotes}Synthesis and Processing{close_quotes} while the second is centered around {open_quotes}Limiting Features in Transport Properties of High T{sub c} Materials{close_quotes}.

  13. Removal of Triphenylmethane Dyes by Bacterial Consortium

    Directory of Open Access Journals (Sweden)

    Jihane Cheriaa

    2012-01-01

    Full Text Available A new consortium of four bacterial isolates (Agrobacterium radiobacter; Bacillus spp.; Sphingomonas paucimobilis, and Aeromonas hydrophila-(CM-4 was used to degrade and to decolorize triphenylmethane dyes. All bacteria were isolated from activated sludge extracted from a wastewater treatment station of a dyeing industry plant. Individual bacterial isolates exhibited a remarkable color-removal capability against crystal violet (50 mg/L and malachite green (50 mg/L dyes within 24 h. Interestingly, the microbial consortium CM-4 shows a high decolorizing percentage for crystal violet and malachite green, respectively, 91% and 99% within 2 h. The rate of chemical oxygen demand (COD removal increases after 24 h, reaching 61.5% and 84.2% for crystal violet and malachite green, respectively. UV-Visible absorption spectra, FTIR analysis and the inspection of bacterial cells growth indicated that color removal by the CM-4 was due to biodegradation. Evaluation of mutagenicity by using Salmonella typhimurium test strains, TA98 and TA100 studies revealed that the degradation of crystal violet and malachite green by CM-4 did not lead to mutagenic products. Altogether, these results demonstrated the usefulness of the bacterial consortium in the treatment of the textile dyes.

  14. PET and SPECT Imaging of Tumor Biology: New Approaches towards Oncology Drug Discovery and Development.

    Science.gov (United States)

    Van Dort, Marcian E; Rehemtulla, Alnawaz; Ross, Brian D

    2008-01-01

    Spiraling drug developmental costs and lengthy time-to-market introduction are two critical challenges facing the pharmaceutical industry. The clinical trials success rate for oncology drugs is reported to be 5% as compared to other therapeutic categories (11%) with most failures often encountered late in the clinical development process. PET and SPECT nuclear imaging technologies could play an important role in facilitating the drug development process improving the speed, efficiency and cost of drug development. This review will focus on recent studies of PET and SPECT radioligands in oncology and their application in the investigation of tumor biology. The use of clinically-validated radioligands as imaging-based biomarkers in oncology could significantly impact new cancer therapeutic development.

  15. From Patient-Specific Mathematical Neuro-Oncology to Precision Medicine

    Directory of Open Access Journals (Sweden)

    Anne eBaldock

    2013-04-01

    Full Text Available Gliomas are notoriously aggressive, malignant brain tumors that have variable response to treatment. These patients often have poor prognosis, informed primarily by histopathology. Mathematical neuro-oncology (MNO is a young and burgeoning field that leverages mathematical models to predict and quantify response to therapies. These mathematical models can form the basis of modern precision medicine approaches to tailor therapy in a patient-specific manner. Patient specific models (PSMs can be used to overcome imaging limitations, improve prognostic predictions, stratify patients and assess treatment response in silico. The information gleaned from such models can aid in the construction and efficacy of clinical trials and treatment protocols, accelerating the pace of clinical research in the war on cancer. This review focuses on the growing translation of PSM to clinical neuro-oncology. It will also provide a forward-looking view on a new era of patient-specific mathematical neuro-oncology.

  16. Phase III Randomized Study of 4 Weeks of High-Dose Interferon-α-2b in Stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E1697).

    Science.gov (United States)

    Agarwala, Sanjiv S; Lee, Sandra J; Yip, Waiki; Rao, Uma N; Tarhini, Ahmad A; Cohen, Gary I; Reintgen, Douglas S; Evans, Terry L; Brell, Joanna M; Albertini, Mark R; Atkins, Michael B; Dakhil, Shaker R; Conry, Robert M; Sosman, Jeffrey A; Flaherty, Lawrence E; Sondak, Vernon K; Carson, William E; Smylie, Michael G; Pappo, Alberto S; Kefford, Richard F; Kirkwood, John M

    2017-03-10

    Purpose To test the efficacy of 4 weeks of intravenous (IV) induction with high-dose interferon (IFN) as part of the Eastern Cooperative Oncology Group regimen compared with observation (OBS) in patients with surgically resected intermediate-risk melanoma. Patients and Methods In this intergroup international trial, eligible patients had surgically resected cutaneous melanoma in the following categories: (1) T2bN0, (2) T3a-bN0, (3) T4a-bN0, and (4) T1-4N1a-2a (microscopic). Patients were randomly assigned to receive IFN α-2b at 20 MU/m(2)/d IV for 5 days (Monday to Friday) every week for 4 weeks (IFN) or OBS. Stratification factors were pathologic lymph node status, lymph node staging procedure, Breslow depth, ulceration of the primary lesion, and disease stage. The primary end point was relapse-free survival. Secondary end points included overall survival, toxicity, and quality of life. Results A total of 1,150 patients were randomly assigned. At a median follow-up of 7 years, the 5-year relapse-free survival rate was 0.70 (95% CI, 0.66 to 0.74) for OBS and 0.70, (95% CI, 0.66 to 0.74) for IFN ( P = .964). The 5-year overall survival rate was 0.83 (95% CI, 0.79 to 0.86) for OBS and 0.83 (95% CI, 0.80 to 0.86) for IFN ( P = .558). Treatment-related grade 3 and higher toxicity was 4.6% versus 57.9% for OBS and IFN, respectively ( P weeks of IV induction as part of the Eastern Cooperative Oncology Group high-dose IFN regimen is not better than OBS alone for patients with intermediate-risk melanoma as defined in this trial.

  17. Educating medical students about radiation oncology: initial results of the oncology education initiative.

    Science.gov (United States)

    Hirsch, Ariel E; Singh, Deeptej; Ozonoff, Al; Slanetz, Priscilla J

    2007-10-01

    Multidisciplinary cancer care requires the integration of teaching across established educational boundaries. Because exposure to oncology and radiation oncology is limited in the undergraduate medical curriculum, the authors introduced an oncology education initiative at their institution. They report on the addition of structured multidisciplinary oncology education to the required radiology core clerkship. An institutional-based cohort study of fourth-year medical students rotating through a required clerkship in radiology at Boston University School of Medicine was conducted, beginning with the class of 2007. An educational questionnaire measuring the perceived quality of oncology education before and after exposure to a structured didactic program was administered. Of the 149 fourth-year students, 121 (81%) have completed the didactics of the initiative. Although 68 of 121 (56%) students reported having limited exposure to cancer care in the clinical years, 107 of 121 (88%) were motivated to learn more about the subject, and 100 of 121 (83%) reported a better understanding of the multidisciplinary nature of cancer care after this oncology education initiative. One hundred ten of 121 (91%) felt that the radiology clerkship was an opportune time to receive oncology and radiation oncology teaching. As a result of the initiative, 32% of the students pursued advanced training in radiation oncology. Of students who before the initiative were not planning on taking oncology electives, 70 of 99 (71%) agreed or strongly agreed that the lecture motivated them to learn more about the subject, and 43 of 99 (43%) agreed or strongly agreed that the lecture motivated them to take oncology electives. Systematic exposure to multidisciplinary oncology education as part of a radiology core clerkship provides an excellent opportunity for the integrated teaching of oncologic principles and patient management. This type of experience addresses an important yet underrepresented

  18. Response evaluation criteria for solid tumours in dogs (v1.0): a Veterinary Cooperative Oncology Group (VCOG) consensus document.

    Science.gov (United States)

    Nguyen, S M; Thamm, D H; Vail, D M; London, C A

    2015-09-01

    In veterinary medical oncology, there is currently no standardized protocol for assessing response to therapy in solid tumours. The lack of such a formalized guideline makes it challenging to critically compare outcome measures across various treatment protocols. The Veterinary Cooperative Oncology Group (VCOG) membership consensus document presented here is based on the recommendations of a subcommittee of American College of Veterinary Internal Medicine (ACVIM) board-certified veterinary oncologists. This consensus paper has used the human response evaluation criteria in solid tumours (RECIST v1.1) as a framework to establish standard procedures for response assessment in canine solid tumours that is meant to be easy to use, repeatable and applicable across a variety of clinical trial structures in veterinary oncology. It is hoped that this new canine RECIST (cRECIST v1.0) will be adopted within the veterinary oncology community and thereby facilitate the comparison of current and future treatment protocols used for companion animals with cancer.

  19. Nutrition support in surgical oncology.

    Science.gov (United States)

    Huhmann, Maureen B; August, David A

    2009-01-01

    This review article, the second in a series of articles to examine the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, evaluates the evidence related to the use of nutrition support in surgical oncology patients. Cancer patients develop complex nutrition issues. Nutrition support may be indicated in malnourished cancer patients undergoing surgery, depending on individual patient characteristics. As with the first article in this series, this article provides background concerning nutrition issues in cancer patients, as well as discusses the role of nutrition support in the care of surgical cancer patients. The goal of this review is to enrich the discussion contained in the clinical guidelines as they relate to recommendations made for surgical patients, cite the primary literature more completely, and suggest updates to the guideline statements in light of subsequently published studies.

  20. Does Cancer Literature Reflect Multidisciplinary Practice? A Systematic Review of Oncology Studies in the Medical Literature Over a 20-Year Period

    Energy Technology Data Exchange (ETDEWEB)

    Holliday, Emma B. [Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Ahmed, Awad A. [Department of Radiation Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida (United States); Yoo, Stella K. [Department of Radiation Oncology, University of Southern California, Los Angeles, California (United States); Jagsi, Reshma [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Hoffman, Karen E., E-mail: KHoffman1@mdanderson.org [Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2015-07-15

    Purpose: Quality cancer care is best delivered through a multidisciplinary approach requiring awareness of current evidence for all oncologic specialties. The highest impact journals often disseminate such information, so the distribution and characteristics of oncology studies by primary intervention (local therapies, systemic therapies, and targeted agents) were evaluated in 10 high-impact journals over a 20-year period. Methods and Materials: Articles published in 1994, 2004, and 2014 in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Lancet Oncology, Journal of Clinical Oncology, Annals of Oncology, Radiotherapy and Oncology, International Journal of Radiation Oncology, Biology, Physics, Annals of Surgical Oncology, and European Journal of Surgical Oncology were identified. Included studies were prospectively conducted and evaluated a therapeutic intervention. Results: A total of 960 studies were included: 240 (25%) investigated local therapies, 551 (57.4%) investigated systemic therapies, and 169 (17.6%) investigated targeted therapies. More local therapy trials (n=185 [77.1%]) evaluated definitive, primary treatment than systemic (n=178 [32.3%]) or targeted therapy trials (n=38 [22.5%]; P<.001). Local therapy trials (n=16 [6.7%]) also had significantly lower rates of industry funding than systemic (n=207 [37.6%]) and targeted therapy trials (n=129 [76.3%]; P<.001). Targeted therapy trials represented 5 (2%), 38 (10.2%), and 126 (38%) of those published in 1994, 2004, and 2014, respectively (P<.001), and industry-funded 48 (18.9%), 122 (32.6%), and 182 (54.8%) trials, respectively (P<.001). Compared to publication of systemic therapy trial articles, articles investigating local therapy (odds ratio: 0.025 [95% confidence interval: 0.012-0.048]; P<.001) were less likely to be found in high-impact general medical journals. Conclusions: Fewer studies evaluating local therapies, such as surgery and radiation, are published in

  1. Clinical Trials in Your Community

    Science.gov (United States)

    The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.

  2. Adjuvant low-dose interleukin-2 (IL-2) plus interferon-α (IFN-α) in operable renal cell carcinoma (RCC): a phase III, randomized, multicentre trial of the Italian Oncology Group for Clinical Research (GOIRC).

    Science.gov (United States)

    Passalacqua, Rodolfo; Caminiti, Caterina; Buti, Sebastiano; Porta, Camillo; Camisa, Roberta; Braglia, Luca; Tomasello, Gianluca; Vaglio, Augusto; Labianca, Roberto; Rondini, Ermanno; Sabbatini, Roberto; Nastasi, Giuseppe; Artioli, Fabrizio; Prati, Andrea; Potenzoni, Michele; Pezzuolo, Debora; Oliva, Elena; Alberici, Federico; Buzio, Carlo

    2014-01-01

    There is currently no standard therapy to reduce the recurrence rate after surgery for renal cell carcinoma (RCC). The aim of this study was to assess efficacy and safety of adjuvant treatment with low doses of interleukin-2 (IL-2)+interferon-α (IFN-α) in operable RCC. The patients were randomized 1:1 to receive a 4-week cycle of low-dose IL-2+IFN-α or observation after primary surgery for RCC. Treatment cycles were repeated every 4 months for the first 2 years and every 6 months for the subsequent 3 years. The primary endpoint was recurrence-free survival (RFS); safety; and overall survival (OS) were secondary endpoints. ClinicalTrials.gov registration number was NCT00502034. 303/310 randomized patients (156 in the immunotherapy arm and 154 in the observation group) were evaluable at the intention-to-treat analyses. The 2 arms were well balanced. At a median follow-up of 52 months (range, 12-151 mo), RFS, and OS were similar, with an estimated hazard ratio (HR) of 0.84 [95% confidence interval (CI), 0.54-1.31; P=0.44] and of 1.07 (95% CI, 0.64-1.79; P=0.79), respectively in the 2 groups. Unplanned, subgroup analysis showed a positive effect of the treatment for patients with age 60 years and younger, pN0, tumor grades 1-2, and pT3a stage. Among patients with the combined presence of ≥ 2 of these factors, immunotherapy had a positive effect on RFS (HR=0.44; 95% CI, 0.24-0.82; P ≤ 0.01), whereas patients with <2 factors in the treatment arm exhibited a significant poorer OS (HR=2.27; 95% CI, 1.03-5.03 P=0.037). Toxicity of immunotherapy was mild and limited to World Health Organization grade 1-2 in most cases. Adjuvant immunotherapy with IL-2+IFN-α showed no RFS or OS improvement in RCC patients who underwent radical surgery. The results of subset analysis here presented are only hypothesis generating.

  3. Impact of liposomal doxorubicin-based adjuvant chemotherapy on autonomy in women over 70 with hormone-receptor-negative breast carcinoma: A French Geriatric Oncology Group (GERICO) phase II multicentre trial.

    Science.gov (United States)

    Brain, Etienne G C; Mertens, Cécile; Girre, Véronique; Rousseau, Frédérique; Blot, Emmanuel; Abadie, Sophie; Uwer, Lionel; Bourbouloux, Emmanuelle; Van Praagh-Doreau, Isabelle; Mourey, Loic; Kirscher, Sylvie; Laguerre, Brigitte; Fourme, Emmanuelle; Luneau, Sylvia; Genève, Jean; Debled, Marc

    2011-10-01

    Breast cancer is a disease of ageing. Functional independence in elderly patients, measured with the Katz activities of daily living (ADL) scale, predicts overall survival and the need for welfare support. Few prospective studies have examined the feasibility of adjuvant chemotherapy and its impact on autonomy in women over 70 years of age with high-risk breast cancer. This multicentre phase II trial was designed to assess the impact of adjuvant anthracycline-based chemotherapy on these patients' autonomy. In a two-stage Fleming design, women aged ≥70 years with histologically proven hormone-receptor-negative early breast cancer and a significant risk of recurrence (pN+ or "high risk" pN0) received 4 cycles of nonpegylated liposomal doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2) every 3 weeks postoperatively, on an outpatient basis. The primary endpoint was the change in the ADL score during chemotherapy. Secondary endpoints include comprehensive geriatric, quality-of-life and acceptability assessments, tolerability, and long-term outcome. The results for the primary endpoint and other scales at completion of adjuvant chemotherapy are reported here, while long-term follow-up is not yet complete. Forty patients (median age 75 [70-82]) were enrolled between February 2006 and November 2007. Chemotherapy had no deleterious impact on ADL, cognition, mental status, or the frequency of comorbidities. In contrast, the number of patients at risk of malnutrition, based on the Mini Nutritional Assessment, more than doubled between baseline and the end of chemotherapy, rising from 15% to 38%. Quality-of-life deteriorated in terms of social and role functioning, likely owing to fatigue, loss of appetite, nausea and vomiting. Treatment acceptability was good. The main adverse effect was neutropenia, 15% of the patients experiencing febrile neutropenia. No cardiac toxicity or toxic deaths occurred. This study demonstrates the feasibility of an adjuvant chemotherapy

  4. The impact of genomics on oncology nursing.

    Science.gov (United States)

    Beamer, Laura Curr; Linder, Lauri; Wu, Bohua; Eggert, Julia

    2013-12-01

    Since 2003, genetics and genomics information has led to exciting new diagnostics, prognostics, and treatment options in oncology practice. Profiling of cancers offers providers insight into treatment and prognostic factors. Germline testing provides an individual with information for surveillance or therapy that may help them prevent cancer in their lifetime and options for family members as yet untouched by malignancy. This offers a challenge for oncology nurses and other oncology health care providers to become comfortable with incorporating education about genetics/genomics into their clinical practice and patient education.

  5. PET-Based Thoracic Radiation Oncology.

    Science.gov (United States)

    Simone, Charles B; Houshmand, Sina; Kalbasi, Anusha; Salavati, Ali; Alavi, Abass

    2016-07-01

    Fluorodeoxyglucose-PET is increasingly being integrated into multiple aspects of oncology. PET/computed tomography (PET/CT) has become especially important in radiation oncology. With the increasing use of advanced techniques like intensity-modulated radiation therapy and proton therapy, PET/CT scans have played critical roles in the target delineation of tumors for radiation oncologists delivering conformal treatment techniques. Use of PET/CT is well established in lung cancer and several other thoracic malignancies. This article details the current uses of PET/CT in thoracic radiation oncology with a focus on lung cancer and describes expected future roles of PET/CT for thoracic tumors.

  6. The Danish Neuro-Oncology Registry

    DEFF Research Database (Denmark)

    Hansen, Steinbjørn

    2016-01-01

    AIM OF DATABASE: The Danish Neuro-Oncology Registry (DNOR) was established by the Danish Neuro-Oncology Group as a national clinical database. It was established for the purpose of supporting research and development in adult patients with primary brain tumors in Denmark. STUDY POPULATION: DNOR has...... advantage of reporting indicators is the related multidisciplinary discussions giving a better understanding of what actually is going on, thereby facilitating the work on adjusting the national guidelines in the Danish Neuro-Oncology Group. CONCLUSION: The establishment of DNOR has optimized the quality...

  7. Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal.

    Directory of Open Access Journals (Sweden)

    Kan Yonemori

    Full Text Available BACKGROUND: The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis. METHODS/PRINCIPAL FINDINGS: Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005-2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%. CONCLUSION/SIGNIFICANCE: Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.

  8. An interprofessionally developed geriatric oncology curriculum for hematology–oncology fellows

    Science.gov (United States)

    Eid, Ahmed; Hughes, Caren; Karuturi, Meghan; Reyes, Connie; Yorio, Jeffrey; Holmes, Holly

    2016-01-01

    Objective Because the cancer population is aging, interprofessional education incorporating geriatric principles is essential to providing adequate training for oncology fellows. We report the targeted needs assessment, content, and evaluation tools for our geriatric oncology curriculum at MD Anderson Cancer Center. Methods A team comprising a geriatrician, a medical oncologist, an oncology PharmD, an oncology advanced nurse practitioner, and two oncology chief fellows developed the geriatric oncology curriculum. First, a general needs assessment was conducted by reviewing the literature and medical societies’ publications and by consulting experts. A targeted needs assessment was then conducted by reviewing the fellows’ evaluations of the geriatric oncology rotation and by interviewing fellows and recently graduated oncology faculty. Results Geriatric assessment, pharmacology, and psychosocial knowledge skills were the three identified areas of educational need. Curriculum objectives and an evaluation checklist were developed to evaluate learners in the three identified areas. The checklist content was validated by consulting experts in the field. Online materials, including a curriculum, a geriatric pharmacology job aid, and pharmacology cases, were also developed and delivered as part of the curriculum. Conclusion An interprofessional team approach was a successful method for identifying areas of learners’ educational needs, which in turn helped us develop an integrated geriatric oncology curriculum. The curriculum is currently being piloted and evaluated. PMID:25487037

  9. [Rethinking clinical research in surgical oncology. From comic opera to quality control].

    Science.gov (United States)

    Evrard, Serge

    2016-01-01

    The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation.

  10. Cardio-Oncology: How New Targeted Cancer Therapies and Precision Medicine Can Inform Cardiovascular Discovery.

    Science.gov (United States)

    Bellinger, Andrew M; Arteaga, Carlos L; Force, Thomas; Humphreys, Benjamin D; Demetri, George D; Druker, Brian J; Moslehi, Javid J

    2015-12-01

    Cardio-oncology (the cardiovascular care of cancer patients) has developed as a new translational and clinical field based on the expanding repertoire of mechanism-based cancer therapies. Although these therapies have changed the natural course of many cancers, several may also lead to cardiovascular complications. Many new anticancer drugs approved over the past decade are "targeted" kinase inhibitors that interfere with intracellular signaling contributing to tumor progression. Unexpected cardiovascular and cardiometabolic effects of patient treatment with these inhibitors have provided unique insights into the role of kinases in human cardiovascular biology. Today, an ever-expanding number of cancer therapies targeting novel kinases and other specific cellular and metabolic pathways are being developed and tested in oncology clinical trials. Some of these drugs may affect the cardiovascular system in detrimental ways and others perhaps in beneficial ways. We propose that the numerous ongoing oncology clinical trials are an opportunity for closer collaboration between cardiologists and oncologists to study the cardiovascular and cardiometabolic changes caused by the modulation of these pathways in patients. In this regard, cardio-oncology represents an opportunity and a novel platform for basic and translational investigation and can serve as a potential avenue for optimization of anticancer therapies and for cardiovascular research and drug discovery.

  11. Complementary and alternative medicine in oncology nursing.

    Science.gov (United States)

    Somani, Salima; Ali, Fauziya; Saeed Ali, Tazeen; Sulaiman Lalani, Nasreen

    Use of complementary and alternative medicine (CAM) has increased globally, particularly among oncology patients. This study investigated the knowledge, experience and attitudes of oncology nurses towards CAM. A quantitative study was conducted in tertiary care hospitals in Karachi, Pakistan, where 132 oncology nurses were surveyed. The survey revealed that more than 50% of nurses had never heard about many of the CAM therapies used in Pakistan. Approximately 65% of the nurses had knowledge about prayer and less than 30% had experience of CAM education or training. In addition, the majority of nurses had seen patients using CAM and felt that their health status could be enhanced with the use of CAM. This study showed that oncology nurses had a positive experience of and attitude towards CAM, although they needed to enhance their knowledge of it to maximise patient satisfaction and quality of care.

  12. Organisational design for an integrated oncological department

    NARCIS (Netherlands)

    Meiss-de Haas, Ch.L.; Falkmann, H.; Douma, J.; Van Gassel, J.G.; Peters, W.G.; Van Mierlo, R.; Van Turnhout, J.M.; Verhagen, C.A.H.H.V.M.; Schrijvers, A.J.P.

    2001-01-01

    Objective: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT) analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated

  13. International Cancer Proteogenome Consortium | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The International Cancer Proteogenome Consortium (ICPC), is a voluntary scientific organization that provides a forum for collaboration among some of the world's leading cancer and proteogenomic research centers.

  14. Latest Developments of the Isprs Student Consortium

    Science.gov (United States)

    Detchev, I.; Kanjir, U.; Reyes, S. R.; Miyazaki, H.; Aktas, A. F.

    2016-06-01

    The International Society for Photogrammetry and Remote Sensing (ISPRS) Student Consortium (SC) is a network for young professionals studying or working within the fields of photogrammetry, remote sensing, Geographical Information Systems (GIS), and other related geo-spatial sciences. The main goal of the network is to provide means for information exchange for its young members and thus help promote and integrate youth into the ISPRS. Over the past four years the Student Consortium has successfully continued to fulfil its mission in both formal and informal ways. The formal means of communication of the SC are its website, newsletter, e-mail announcements and summer schools, while its informal ones are multiple social media outlets and various social activities during student related events. The newsletter is published every three to four months and provides both technical and experiential content relevant for the young people in the ISPRS. The SC has been in charge or at least has helped with organizing one or more summer schools every year. The organization's e-mail list has over 1,100 subscribers, its website hosts over 1,300 members from 100 countries across the entire globe, and its public Facebook group currently has over 4,500 joined visitors, who connect among one another and share information relevant for their professional careers. These numbers show that the Student Consortium has grown into a significant online-united community. The paper will present the organization's on-going and past activities for the last four years, its current priorities and a strategic plan and aspirations for the future four-year period.

  15. [Interests of applied anthropology to oncology].

    Science.gov (United States)

    Soum-Pouyalet, Fanny; Hubert, Annie; Dilhuydy, Jean-Marie

    2008-01-01

    From now on the introduction of social and human sciences studies in the field of oncology has not always been conclusive. This article aims to analyze the bounds that border the meeting and the understanding between physicians, patients and anthropologists. It also treats the problems due to the introduction of applied anthropology in the field of oncology and points up the interests and practical contributions that this disciplinary bring and could bring.

  16. Car-2-Car Communication Consortium - Manifesto

    OpenAIRE

    Baldessari, Roberto; Bödekker, Bert; Deegener, Matthias; Festag, Andreas; Franz, Walter; Kellum, C. Christopher; Kosch, Timo; Kovacs, Andras; Lenardi, Massimiliano; Menig, Cornelius; Peichl, Timo; Röckl, Matthias; Seeberger, Dieter; Straßberger, Markus; Stratil, Hannes

    2007-01-01

    This document summarizes and describes the main building blocks of the Car2X Communication System as it is pursued by the Car2Car Communication Consortium (C2C-CC). “Car2X” means interactions among cars, between cars and infrastructures, and viceversa. It provides interested readers with an introduction to Car2X communications. It is intended to be a living document which will be complemented according to the progress of the work of the C2C-CC. One main objective of this document is to give i...

  17. University Research Consortium annual review meeting program

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    This brochure presents the program for the first annual review meeting of the University Research Consortium (URC) of the Idaho National Engineering Laboratory (INEL). INEL is a multiprogram laboratory with a distinctive role in applied engineering. It also conducts basic science research and development, and complex facility operations. The URC program consists of a portfolio of research projects funded by INEL and conducted at universities in the United States. In this program, summaries and participant lists for each project are presented as received from the principal investigators.

  18. Midwest Superconductivity Consortium: 1994 Progress report

    Energy Technology Data Exchange (ETDEWEB)

    1995-01-01

    The mission of the Midwest Superconductivity Consortium, MISCON, is to advance the science and understanding of high {Tc} superconductivity. During the past year, 27 projects produced over 123 talks and 139 publications. Group activities and interactions involved 2 MISCON group meetings (held in August and January); with the second MISCON Workshop held in August; 13 external speakers; 79 collaborations (with universities, industry, Federal laboratories, and foreign research centers); and 48 exchanges of samples and/or measurements. Research achievements this past year focused on understanding the effects of processing phenomena on structure-property interrelationships and the fundamental nature of transport properties in high-temperature superconductors.

  19. Exploring resilience in paediatric oncology nursing staff.

    Science.gov (United States)

    Zander, Melissa; Hutton, Alison; King, Lindy

    2013-01-01

    Resilience has been suggested as an important coping strategy for nurses working in demanding settings, such as paediatric oncology. This qualitative study explored paediatric oncology nurses' perceptions of their development of resilience and how this resilience underpinned their ability to deal with work-related stressors. Five paediatric oncology nurses were interviewed about their understanding of the concept of resilience, their preferred coping mechanisms, and their day-today work in paediatric oncology. Using thematic analysis, the interviews were subsequently grouped together into seventeen initial themes. These themes were then grouped into seven major aspects that described how the participants perceived resilience underpinned their work. These "seven aspects of forming resilience" contributed to an initial understanding of how paediatric oncology nurses develop resilience in the face of their personal and professional challenges. Several key strategies derived from the findings, such as improved rostering, support to a nurse's friend and family, and a clinical support nursing role, could be implemented at an organizational level to support resilience development within the paediatric oncology setting.

  20. Workflow-driven clinical decision support for personalized oncology.

    Science.gov (United States)

    Bucur, Anca; van Leeuwen, Jasper; Christodoulou, Nikolaos; Sigdel, Kamana; Argyri, Katerina; Koumakis, Lefteris; Graf, Norbert; Stamatakos, Georgios

    2016-07-21

    The adoption in oncology of Clinical Decision Support (CDS) may help clinical users to efficiently deal with the high complexity of the domain, lead to improved patient outcomes, and reduce the current knowledge gap between clinical research and practice. While significant effort has been invested in the implementation of CDS, the uptake in the clinic has been limited. The barriers to adoption have been extensively discussed in the literature. In oncology, current CDS solutions are not able to support the complex decisions required for stratification and personalized treatment of patients and to keep up with the high rate of change in therapeutic options and knowledge. To address these challenges, we propose a framework enabling efficient implementation of meaningful CDS that incorporates a large variety of clinical knowledge models to bring to the clinic comprehensive solutions leveraging the latest domain knowledge. We use both literature-based models and models built within the p-medicine project using the rich datasets from clinical trials and care provided by the clinical partners. The framework is open to the biomedical community, enabling reuse of deployed models by third-party CDS implementations and supporting collaboration among modelers, CDS implementers, biomedical researchers and clinicians. To increase adoption and cope with the complexity of patient management in oncology, we also support and leverage the clinical processes adhered to by healthcare organizations. We design an architecture that extends the CDS framework with workflow functionality. The clinical models are embedded in the workflow models and executed at the right time, when and where the recommendations are needed in the clinical process. In this paper we present our CDS framework developed in p-medicine and the CDS implementation leveraging the framework. To support complex decisions, the framework relies on clinical models that encapsulate relevant clinical knowledge. Next to

  1. Interventional radiology in pediatric oncology

    Energy Technology Data Exchange (ETDEWEB)

    Hoffer, Fredric A. [Division of Diagnostic Imaging, Department of Radiological Sciences, St. Jude Children' s Research Hospital, 332 N. Lauderdale St., Memphis, TN 38105 (United States)]. E-mail: fred.hoffer@stjude.org

    2005-01-01

    There are many radiological interventions necessary for pediatric oncology patients, some of which may be covered in other articles in this publication. I will discuss a number of interventions including percutaneous biopsy for solid tumor and hematological malignancy diagnosis or recurrence, for the diagnosis of graft versus host disease after stem cell or bone marrow transplantation, and for the diagnosis of complications of immunosuppression such as invasive pulmonary aspergillosis. In the past, tumor localization techniques have been necessary to biopsy or resect small lesions. However improved guidance techniques have allowed for more precise biopsy and the use of thermal ablation instead of excision for local tumor control. A percutaneously placed radio frequency, microwave, laser or cryogen probe can ablate the primary and metastatic tumors of the liver, lung, bone, kidney and other structures in children. This is an alternative treatment for the local control of tumors that may not be amenable to surgery, chemotherapy or radiotherapy. I will also describe how chemoembolization can be used to treat primary or metastatic tumors of the liver that have failed other therapies. This treatment delivers chemotherapy in the hepatic artery infused with emboli to increase the dwell time and concentration of the agents.

  2. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

    OpenAIRE

    de Vries Martine C; Houtlosser Mirjam; Wit Jan M; Engberts Dirk P; Bresters Dorine; Kaspers Gertjan JL; van Leeuwen Evert

    2011-01-01

    Abstract Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1) a narrati...

  3. ASTRO APEx(®) and RO-ILS™ are applicable to medical malpractice in radiation oncology.

    Science.gov (United States)

    Zaorsky, Nicholas G; Ricco, Anthony G; Churilla, Thomas M; Horwitz, Eric M; Den, Robert B

    2016-11-01

    To analyze malpractice trials in radiation oncology and assess how ASTRO APEx(®) and RO-ILS™ apply to such cases. The Westlaw database was reviewed using PICOS/PRISMA methods. Fisher's exact and Mann-Whitney U tests were used to find factors associated with outcomes. Of 34 cases identified, external beam was used in 26 (77%). The most common factors behind malpractice were excessive toxicity (80%) and lack of informed consent (66%). ASTRO APEx pillars and ROI-LS had applicability to all but one case. Factors favoring the defendant included statute of limitations (odds ratio: 8.1; 95% CI: 1.3-50); those favoring the plaintiff included patient death (odds ratio: 0.7; 95% CI: 0.54-0.94). APEx and RO-ILS are applicable to malpractice trials in radiation oncology.

  4. Overview of the carbon products consortium (CPC)

    Energy Technology Data Exchange (ETDEWEB)

    Irwin, C.L. [West Virginia Univ., Morgantown, WV (United States)

    1996-08-01

    The Carbon Products Consortium (CPC) is an industry, university, government cooperative research team which has evolved over the past seven years to produce and evaluate coal-derived feedstocks for carbon products. The members of the Carbon Products Consortium are UCAR Carbon Company, Koppers Industries, CONOCO, Aluminum Company of America, AMOCO Polymers, and West Virginia University. The Carbon and Insulation Materials Technology Group at Oak Ridge National Laboratory, Fiber Materials Inc., and BASF Corporation are affiliates of the CPC. The initial work on coal-derived nuclear graphites was supported by a grant to WVU, UCAR Carbon, and ORNL from the U.S. DOE New Production Reactor program. More recently, the CPC program has been supported through the Fossil Energy Materials program and through PETC`s Liquefaction program. The coal processing technologies involve hydrogenation, extraction by solvents such as N-methyl pyrolidone and toluene, material blending, and calcination. The breadth of carbon science expertise and manufacturing capability available in the CPC enables it to address virtually all research and development issues of importance to the carbon products industry.

  5. BIODEGRADATION OF MTBE BY A MICROORGANISM CONSORTIUM

    Directory of Open Access Journals (Sweden)

    M. Alimohammadi, A. R. Mesdaghinia, M. Mahmoodi, S. Nasseri, A. H. Mahvi and J. Nouri

    2005-10-01

    Full Text Available Methyl Tert-Butyl Ether (MTBE is one of the ether oxygenates which its use has been increased within the last twenty years. This compound is produced from isobutylene and methanol reaction that is used as octane index enhancer and also increases dissolved oxygen in gasoline and decreases carbon monoxide emission in four phased motors because of better combustion of gasoline. High solubility in water (52 g/L, high vapor pressure (0.54 kg/cm3, low absorption to organic carbon of soil and presence of MTBE in the list of potentially-carcinogens of U.S EPA has made its use of great concern. The culture media used in this study was Mineral Salt Medium (MSM. The study lasted for 236 days and in three different concentrations of MTBE of 200, 5 and 0.8 mg/L. A control sample was also used to compare the results. This research studied the isolation methods of microbial consortium in the MTBE polluted soils in Tehran and Abadan petroleum refinery besides MTBE degradation. The results showed the capability of bacteria in consuming MTBE as carbon source. Final microbial isolation was performed with several microbial passages as well as keeping consortium in a certain amount of MTBE as the carbon source.

  6. Fermentative hydrogen production by microbial consortium

    Energy Technology Data Exchange (ETDEWEB)

    Maintinguer, Sandra I.; Fernandes, Bruna S.; Duarte, Iolanda C.S.; Saavedra, Nora Katia; Adorno, M. Angela T.; Varesche, M. Bernadete [Department of Hydraulics and Sanitation, School of Engineering of Sao Carlos, University of Sao Paulo, Av. Trabalhador Sao-carlense, 400, 13566-590 Sao Carlos-SP (Brazil)

    2008-08-15

    Heat pre-treatment of the inoculum associated to the pH control was applied to select hydrogen-producing bacteria and endospores-forming bacteria. The source of inoculum to the heat pre-treatment was from a UASB reactor used in the slaughterhouse waste treatment. The molecular biology analyses indicated that the microbial consortium presented microorganisms affiliated with Enterobacter cloacae (97% and 98%), Clostridium sp. (98%) and Clostridium acetobutyricum (96%), recognized as H{sub 2} and volatile acids' producers. The following assays were carried out in batch reactors in order to verify the efficiencies of sucrose conversion to H{sub 2} by the microbial consortium: (1) 630.0 mg sucrose/L, (2) 1184.0 mg sucrose/L, (3) 1816.0 mg sucrose/L and (4) 4128.0 mg sucrose/L. The subsequent yields were obtained as follows: 15% (1.2 mol H{sub 2}/mol sucrose), 20% (1.6 mol H{sub 2}/mol sucrose), 15% (1.2 mol H{sub 2}/mol sucrose) and 4% (0.3 mol H{sub 2}/mol sucrose), respectively. The intermediary products were acetic acid, butyric acid, methanol and ethanol in all of the anaerobic reactors. (author)

  7. The NIH Extracellular RNA Communication Consortium

    Directory of Open Access Journals (Sweden)

    Alexandra M. Ainsztein

    2015-08-01

    Full Text Available The Extracellular RNA (exRNA Communication Consortium, funded as an initiative of the NIH Common Fund, represents a consortium of investigators assembled to address the critical issues in the exRNA research arena. The overarching goal is to generate a multi-component community resource for sharing fundamental scientific discoveries, protocols, and innovative tools and technologies. The key initiatives include (a generating a reference catalogue of exRNAs present in body fluids of normal healthy individuals that would facilitate disease diagnosis and therapies, (b defining the fundamental principles of exRNA biogenesis, distribution, uptake, and function, as well as development of molecular tools, technologies, and imaging modalities to enable these studies, (c identifying exRNA biomarkers of disease, (d demonstrating clinical utility of exRNAs as therapeutic agents and developing scalable technologies required for these studies, and (e developing a community resource, the exRNA Atlas, to provide the scientific community access to exRNA data, standardized exRNA protocols, and other useful tools and technologies generated by funded investigators.

  8. Phosphorus mobilizing consortium Mammoth P™ enhances plant growth

    Directory of Open Access Journals (Sweden)

    Peter Baas

    2016-06-01

    Full Text Available Phosphorus (P is a critical nutrient used to maximize plant growth and yield. Current agriculture management practices commonly experience low plant P use efficiency due to natural chemical sorption and transformations when P fertilizer is applied to soils. A perplexing challenge facing agriculture production is finding sustainable solutions to deliver P more efficiently to plants. Using prescribed applications of specific soil microbial assemblages to mobilize soil bound—P to improve crop nutrient uptake and productivity has rarely been employed. We investigated whether inoculation of soils with a bacterial consortium developed to mobilize soil P, named Mammoth PTM, could increase plant productivity. In turf, herbs, and fruits, the combination of conventional inorganic fertilizer combined with Mammoth PTM increased productivity up to twofold compared to the fertilizer treatments without the Mammoth PTM inoculant. Jalapeño plants were found to bloom more rapidly when treated with either Mammoth P. In wheat trials, we found that Mammoth PTM by itself was able to deliver yields equivalent to those achieved with conventional inorganic fertilizer applications and improved productivity more than another biostimulant product. Results from this study indicate the substantial potential of Mammoth PTM to enhance plant growth and crop productivity.

  9. Gene expression profiles predictive of outcome and age in infant acute lymphoblastic leukemia: A Children's Oncology Group study

    NARCIS (Netherlands)

    H. Kang; C.S. Wilson (Carla); R. Harvey (R.); I.-M. Chen (I.-Ming); M.H. Murphy (Maurice); S.R. Atlas (Susan); E.J. Bedrick (Edward); M. Devidas (Meenakshi); A.J. Carroll; B.W. Robinson (Blaine); R.W. Stam (Ronald); M.G. Valsecchi (Maria Grazia); R. Pieters (Rob); N.A. Heerema (Nyla); J.M. Hilden (Joanne); C.A. Felix (Carolyn); G.H. Reaman (Gregory); B. Camitta (Bruce); N.J. Winick (Naomi); W.L. Carroll (William); S.D. Dreyer; S.P. Hunger (Stephen); S.F. Willman (Sami )

    2012-01-01

    textabstractGene expression profiling was performed on 97 cases of infant ALL from Children's Oncology Group Trial P9407. Statistical modeling of an outcome predictor revealed 3 genes highly predictive of event-free survival (EFS), beyond age and MLL status: FLT3, IRX2, and TACC2. Low FLT3 expressio

  10. [Internet: a fundamental tool for the retrieval of the information useful for medical research and health care in oncology].

    Science.gov (United States)

    Bianciardi, L; D'Agata, A

    2002-02-01

    Internet represents an essential aid for the professional updating of physicians and researches. Also for the research and therapy in oncology, Internet provides important such as bibliographic data, trials and guidelines with full text, as well as epidemiologic and statistical data. Some of the most authoritative sites are indicated.

  11. Stromal targets for fluorescent-guided oncologic surgery

    Directory of Open Access Journals (Sweden)

    Martin C. Boonstra

    2015-11-01

    Full Text Available Pre-operative imaging techniques are essential for tumor detection and diagnosis, but offer limited help during surgery. Recently the applicability of imaging during oncologic surgery has been recognized, using near infrared fluorescent dyes conjugated to targeting antibodies, peptides or other vehicles. Image-guided oncologic surgery (IGOS assists the surgeon to distinguish tumor from normal tissue during operation, and can aid in recognizing vital structures. IGOS relies on an optimized combination of a dedicated fluorescent camera system and specific probes for targeting.IGOS probes for clinical use are not widely available yet, but numerous pre-clinical studies have been published and clinical trials are being established or prepared. Most of the investigated probes are based on antibodies or peptides against proteins on the membranes of malignant cells, whereas others are directed against stromal cells. Targeting stroma cells for IGOS has several advantages. Besides the high stromal content in more aggressive tumor types, the stroma is often primarily located at the periphery/invasive front of the tumor, which makes stromal targets particularly suited for imaging purposes. Moreover, because stroma up-regulation is a physiological reaction, most proteins to be targeted on these cells are ‘universal’ and not derived from a specific genetic variation, as is the case with many upregulated proteins on malignant cancer cells.

  12. [Renaissance of immuno-oncology for urological tumors : Current status].

    Science.gov (United States)

    Grimm, M-O; Winkler, Y; Fetter, I; Oppel-Heuchel, H

    2016-05-01

    With the advent of immune checkpoint inhibitors, immunotherapy has gained new importance in oncology. Current research is focused on the cytotoxic T‑lymphocyte antigen 4 (CTLA4), programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) immune checkpoints. The CTLA4 antibody ipilimumab (melanoma) as well as the PD-1 antibodies nivolumab (melanoma, non-small cell lung cancer and renal cell carcinoma) and pembrolizumab (melanoma) are approved for the treatment of metastatic disease in Europe. Immune checkpoint inhibitors (re)activate the immune system against cancer cells and appear to be more effective than current standards for many tumors. The toxicity profile is favorable but involves new so-called immune-related side effects, which need to be recognized and treated in time. Immune checkpoint inhibitors are also currently being tested in uro-oncology in phase 3 trials relevant for approval status. Based on this it is to be expected that immune checkpoint inhibitors will become a new standard (as monotherapy or as part of combination therapy) in the early lines of therapy in the near future and replace the previous standard therapies, particularly for metastasized renal cell carcinoma and urothelial cancer.

  13. Intermittent Chemotherapy as a Platform for Testing Novel Agents in Patients With Metastatic Castration-Resistant Prostate Cancer: A Department of Defense Prostate Cancer Clinical Trials Consortium Randomized Phase II Trial of Intermittent Docetaxel With Prednisone With or Without Maintenance GM-CSF.

    Science.gov (United States)

    Aggarwal, Rahul R; Beer, Tomasz M; Weinberg, Vivian K; Higano, Celestia; Taplin, Mary-Ellen; Ryan, Charles J; Lin, Amy M; Alumkal, Joshi; Graff, Julie N; Nordquist, Luke T; Herrera, Isheen; Small, Eric J

    2015-06-01

    Immunotherapy with granulocyte-macrophage colony-stimulating factor (GM-CSF), an agent that previously demonstrated antitumor activity, was evaluated within an intermittent chemotherapy framework of docetaxel with prednisone (D+P) in metastatic castration-resistant prostate cancer (mCRPC). mCRPC patients with ≥ 50% prostate-specific antigen (PSA) decline after 6 cycles of D+P were randomized to either GM-CSF or observation (Obs). At disease progression (PD), D+P was reinitiated for 6 cycles followed by the same "off chemotherapy" regimen in patients eligible for chemotherapy interruption. The sequence was repeated until PD during chemotherapy, lack of PSA response to chemotherapy, or unacceptable toxicity. The primary end point was time to chemotherapy resistance (TTCR). Of 125 patients enrolled, 52 (42%) experienced ≥ 50% PSA decline on induction D+P and were randomized to GM-CSF (n = 27) or Obs (n = 25). The median time to PD was 3.3 months (95% confidence interval [CI], 2.4-3.5) and 1.5 months (95% CI, 1.5-2.4) during the initial course of GM-CSF and Obs, respectively. Twelve of 26 (46%) patients responded to a second course of D+P. Eleven randomized patients (21%) experienced PD during chemotherapy, precluding accurate assessment of TTCR. The remaining 41 randomized patients discontinued study for lack of PSA response to chemotherapy (n = 8), patient choice to not restart chemotherapy with PSA PD (n = 13), toxicity (n = 7), or study withdrawal (n = 13). Conducting a prospective study in mCRPC with maintenance immunotherapy within the framework of intermittent chemotherapy was feasible. The use of PSA instead of radiographic end points limited the number of evaluable patients. This study provides important insight into designing contemporary intermittent chemotherapy trials with maintenance immunotherapy in patients with advanced prostate cancer. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Immunotherapy Response Assessment in Neuro-Oncology (iRANO): A Report of the RANO Working Group

    Science.gov (United States)

    Okada, Hideho; Weller, Michael; Huang, Raymond; Finocchiaro, Gaetano; Gilbert, Mark R.; Wick, Wolfgang; Ellingson, Benjamin M.; Hashimoto, Naoya; Pollack, Ian F.; Brandes, Alba A.; Franceschi, Enrico; Herold-Mende, Christel; Nayak, Lakshmi; Panigrahy, Ashok; Pope, Whitney B.; Prins, Robert; Sampson, John H.; Wen, Patrick Y.; Reardon, David A.

    2015-01-01

    Immunotherapy represents a promising area of therapy among neuro-oncology patients. However, early phase studies reveal unique challenges associated with assessment of radiological changes reflecting delayed responses or therapy-induced inflammation. Clinical benefit, including long-term survival and tumor regression, can still occur following initial apparent progression or appearance of new lesions. Refinement of response assessment criteria for neuro-oncology patients undergoing immunotherapy is therefore warranted. A multinational and multidisciplinary panel of neuro-oncology immunotherapy experts describes immunotherapy response assessment for neuro-oncology (iRANO) criteria that are based on guidance for determination of tumor progression outlined by the immune-related response criteria (irRC) and the response assessment in neuro-oncology (RANO) working group. Among patients who demonstrate imaging findings meeting RANO criteria for progressive disease (PD) within six months of initiating immunotherapy including the development of new lesions, confirmation of radiographic progression on follow-up imaging is recommended provided that the patient is not significantly worse clinically. The proposed criteria also include guidelines for use of corticosteroids. The role of advanced imaging techniques and measurement of clinical benefit endpoints including neurologic and immunologic functions are reviewed. The iRANO guidelines put forth herein will evolve successively to improve their utility as further experience from immunotherapy trials in neuro-oncology accumulate. PMID:26545842

  15. PET and SPECT Imaging of Tumor Biology: New Approaches towards Oncology Drug Discovery and Development

    OpenAIRE

    Van Dort, Marcian E.; Rehemtulla, Alnawaz; Brian D. Ross

    2008-01-01

    Spiraling drug developmental costs and lengthy time-to-market introduction are two critical challenges facing the pharmaceutical industry. The clinical trials success rate for oncology drugs is reported to be 5% as compared to other therapeutic categories (11%) with most failures often encountered late in the clinical development process. PET and SPECT nuclear imaging technologies could play an important role in facilitating the drug development process improving the speed, efficiency and cos...

  16. Research Biopsies in the Context of Early Phase Oncology Studies: Clinical and Ethical Considerations

    OpenAIRE

    Matilde Saggese; Divyanshu Dua; Emily Simmons; Charlotte Lemech; Hendrik-Tobias Arkenau

    2013-01-01

    The Personalized Medicine approach in oncology is a direct result of an improved understanding of complex tumor biology and advances in diagnostic technologies. In recent years, there has been an increased demand for archival and fresh tumor analysis in early clinical trials to foster proof-of-concept biomarker development, to understand resistance mechanisms, and ultimately to assess biological response. Although phase I studies are aimed at defining drug safety, pharmacokinetics, and to rec...

  17. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology.

    Science.gov (United States)

    Zon, Robin T; Frame, James N; Neuss, Michael N; Page, Ray D; Wollins, Dana S; Stranne, Steven; Bosserman, Linda D

    2016-03-01

    The use of clinical pathways in oncology care is increasingly important to patients and oncology providers as a tool for enhancing both quality and value. However, with increasing adoption of pathways into oncology practice, concerns have been raised by ASCO members and other stakeholders. These include the process being used for pathway development, the administrative burdens on oncology practices of reporting on pathway adherence, and understanding the true impact of pathway use on patient health outcomes. To address these concerns, ASCO's Board of Directors established a Task Force on Clinical Pathways, charged with articulating a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. These recommendations have been approved and adopted by ASCO's Board of Directors on August 12, 2015, and are presented herein.

  18. Strength and weakness of phase I to IV trials, with an emphasis on translational aspects

    OpenAIRE

    Lønning, Per Eystein

    2008-01-01

    Although phase I to III trials represent the standard for introducing new drugs to clinical therapy, there has been increasing demand for translational research in oncology over the past decade. Thus, for most novel therapies such as 'targeted agents', a critical aspect for drug development in oncology has been to select the right patients for therapy. Translational research plays a pivotal role, not only in phase II trials but also in phase I and III and even in phase IV trials. The importan...

  19. Considerations for observational research using large data sets in radiation oncology.

    Science.gov (United States)

    Jagsi, Reshma; Bekelman, Justin E; Chen, Aileen; Chen, Ronald C; Hoffman, Karen; Shih, Ya-Chen Tina; Smith, Benjamin D; Yu, James B

    2014-09-01

    The radiation oncology community has witnessed growing interest in observational research conducted using large-scale data sources such as registries and claims-based data sets. With the growing emphasis on observational analyses in health care, the radiation oncology community must possess a sophisticated understanding of the methodological considerations of such studies in order to evaluate evidence appropriately to guide practice and policy. Because observational research has unique features that distinguish it from clinical trials and other forms of traditional radiation oncology research, the International Journal of Radiation Oncology, Biology, Physics assembled a panel of experts in health services research to provide a concise and well-referenced review, intended to be informative for the lay reader, as well as for scholars who wish to embark on such research without prior experience. This review begins by discussing the types of research questions relevant to radiation oncology that large-scale databases may help illuminate. It then describes major potential data sources for such endeavors, including information regarding access and insights regarding the strengths and limitations of each. Finally, it provides guidance regarding the analytical challenges that observational studies must confront, along with discussion of the techniques that have been developed to help minimize the impact of certain common analytical issues in observational analysis. Features characterizing a well-designed observational study include clearly defined research questions, careful selection of an appropriate data source, consultation with investigators with relevant methodological expertise, inclusion of sensitivity analyses, caution not to overinterpret small but significant differences, and recognition of limitations when trying to evaluate causality. This review concludes that carefully designed and executed studies using observational data that possess these qualities hold

  20. Considerations for Observational Research Using Large Data Sets in Radiation Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Jagsi, Reshma, E-mail: rjagsi@med.umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Bekelman, Justin E. [Departments of Radiation Oncology and Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (United States); Chen, Aileen [Department of Radiation Oncology, Harvard Medical School, Boston, Massachusetts (United States); Chen, Ronald C. [Department of Radiation Oncology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina (United States); Hoffman, Karen [Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Tina Shih, Ya-Chen [Department of Medicine, Section of Hospital Medicine, The University of Chicago, Chicago, Illinois (United States); Smith, Benjamin D. [Department of Radiation Oncology, Division of Radiation Oncology, and Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Yu, James B. [Yale School of Medicine, New Haven, Connecticut (United States)

    2014-09-01

    The radiation oncology community has witnessed growing interest in observational research conducted using large-scale data sources such as registries and claims-based data sets. With the growing emphasis on observational analyses in health care, the radiation oncology community must possess a sophisticated understanding of the methodological considerations of such studies in order to evaluate evidence appropriately to guide practice and policy. Because observational research has unique features that distinguish it from clinical trials and other forms of traditional radiation oncology research, the International Journal of Radiation Oncology, Biology, Physics assembled a panel of experts in health services research to provide a concise and well-referenced review, intended to be informative for the lay reader, as well as for scholars who wish to embark on such research without prior experience. This review begins by discussing the types of research questions relevant to radiation oncology that large-scale databases may help illuminate. It then describes major potential data sources for such endeavors, including information regarding access and insights regarding the strengths and limitations of each. Finally, it provides guidance regarding the analytical challenges that observational studies must confront, along with discussion of the techniques that have been developed to help minimize the impact of certain common analytical issues in observational analysis. Features characterizing a well-designed observational study include clearly defined research questions, careful selection of an appropriate data source, consultation with investigators with relevant methodological expertise, inclusion of sensitivity analyses, caution not to overinterpret small but significant differences, and recognition of limitations when trying to evaluate causality. This review concludes that carefully designed and executed studies using observational data that possess these qualities hold

  1. Urban Consortium Energy Task Force - Year 21 Final Report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-04-01

    The Urban Consortium Energy Task Force (UCETF), comprised of representatives of large cities and counties in the United States, is a subgroup of the Urban Consortium, an organization of the nation's largest cities and counties joined together to identify, develop and deploy innovative approaches and technological solutions to pressing urban issues.

  2. Growth behind the Mirror: The Family Therapy Consortium's Group Process.

    Science.gov (United States)

    Wendorf, Donald J.; And Others

    1985-01-01

    Charts the development of the Family Therapy Consortium, a group that provides supervision and continuing education in family therapy and explores the peer supervision process at work in the consortium. The focus is on individual and group development, which are seen as complementary aspects of the same growth process. (Author/NRB)

  3. International Arid Lands Consortium: A synopsis of accomplishments

    Science.gov (United States)

    Peter F. Ffolliott; Jeffrey O. Dawson; James T. Fisher; Itshack Moshe; Timothy E. Fulbright; W. Carter Johnson; Paul Verburg; Muhammad Shatanawi; Jim P. M. Chamie

    2003-01-01

    The International Arid Lands Consortium (IALC) was established in 1990 to promote research, education, and training activities related to the development, management, and reclamation of arid and semiarid lands in the Southwestern United States, the Middle East, and elsewhere in the world. The Consortium supports the ecological sustainability and environmentally sound...

  4. The virtual atomic and molecular data centre (VAMDC) consortium

    Science.gov (United States)

    Dubernet, M. L.; Antony, B. K.; Ba, Y. A.; Babikov, Yu L.; Bartschat, K.; Boudon, V.; Braams, B. J.; Chung, H.-K.; Daniel, F.; Delahaye, F.; Del Zanna, G.; de Urquijo, J.; Dimitrijević, M. S.; Domaracka, A.; Doronin, M.; Drouin, B. J.; Endres, C. P.; Fazliev, A. Z.; Gagarin, S. V.; Gordon, I. E.; Gratier, P.; Heiter, U.; Hill, C.; Jevremović, D.; Joblin, C.; Kasprzak, A.; Krishnakumar, E.; Leto, G.; Loboda, P. A.; Louge, T.; Maclot, S.; Marinković, B. P.; Markwick, A.; Marquart, T.; Mason, H. E.; Mason, N. J.; Mendoza, C.; Mihajlov, A. A.; Millar, T. J.; Moreau, N.; Mulas, G.; Pakhomov, Yu; Palmeri, P.; Pancheshnyi, S.; Perevalov, V. I.; Piskunov, N.; Postler, J.; Quinet, P.; Quintas-Sánchez, E.; Ralchenko, Yu; Rhee, Y.-J.; Rixon, G.; Rothman, L. S.; Roueff, E.; Ryabchikova, T.; Sahal-Bréchot, S.; Scheier, P.; Schlemmer, S.; Schmitt, B.; Stempels, E.; Tashkun, S.; Tennyson, J.; Tyuterev, Vl G.; Vujčić, V.; Wakelam, V.; Walton, N. A.; Zatsarinny, O.; Zeippen, C. J.; Zwölf, C. M.

    2016-04-01

    The Virtual Atomic and Molecular Data Centre (VAMDC) Consortium is a worldwide consortium which federates atomic and molecular databases through an e-science infrastructure and an organisation to support this activity. About 90% of the inter-connected databases handle data that are used for the interpretation of astronomical spectra and for modelling in many fields of astrophysics. Recently the VAMDC Consortium has connected databases from the radiation damage and the plasma communities, as well as promoting the publication of data from Indian institutes. This paper describes how the VAMDC Consortium is organised for the optimal distribution of atomic and molecular data for scientific research. It is noted that the VAMDC Consortium strongly advocates that authors of research papers using data cite the original experimental and theoretical papers as well as the relevant databases. .

  5. The performance of model-based versus rule-based phase I clinical trials in oncology : A quantitative comparison of the performance of model-based versus rule-based phase I trials with molecularly targeted anticancer drugs over the last 2 years

    NARCIS (Netherlands)

    van Brummelen, E M J; Huitema, A D R; van Werkhoven, E; Beijnen, J H; Schellens, J H M

    2016-01-01

    Phase I studies with anticancer drugs are used to evaluate safety and tolerability and to choose a recommended phase II dose (RP2D). Traditionally, phase I trial designs are rule-based, but for several years there is a trend towards model-based designs. Simulations have shown that model-based design

  6. Challenges and opportunities for monoclonal antibody therapy in veterinary oncology.

    Science.gov (United States)

    Beirão, Breno C B; Raposo, Teresa; Jain, Saurabh; Hupp, Ted; Argyle, David J

    2016-12-01

    Monoclonal antibodies (mAbs) have come to dominate the biologics market in human cancer therapy. Nevertheless, in veterinary medicine, very few clinical trials have been initiated using this form of therapy. Some of the advantages of mAb therapeutics over conventional drugs are high specificity, precise mode of action and long half-life, which favour infrequent dosing of the antibody. Further advancement in the field of biomedical sciences has led to the production of different forms of antibodies, such as single chain antibody fragment, Fab, bi-specific antibodies and drug conjugates for use in diagnostic and therapeutic purposes. This review describes the potential for mAbs in veterinary oncology in supporting both diagnosis and therapy of cancer. The technical and financial hurdles to facilitate clinical acceptance of mAbs are explored and insights into novel technologies and targets that could support more rapid clinical development are offered. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. [New targets and new drugs in thoracic oncology].

    Science.gov (United States)

    Rouviere, D; Bousquet, E; Pons, E; Milia, J-D; Guibert, N; Mazieres, J

    2015-10-01

    A number of mechanisms that drive oncogenesis have been deciphered over the last 20 years. The main oncogenic factors in the field of thoracic oncology are mutations of EGFR, KRAS, and EML4-ALK translocation, which are most often reported in adenocarcinomas. However, new molecular targets have been highlighted recently including BRAF mutations, HER2 or PI3K, new translocations such as ROS1 or KIF5B-RET. Molecular abnormalities have also been identified in tumors other than adenocarcinoma (squamous and small cell carcinoma). Therapeutic strategies have been designed to inhibit these signaling pathways including monoclonal antibodies and tyrosine kinase inhibitors. Some of these molecules are now approved as therapies, others are currently undergoing testing in clinical trials. We here present a review of novel targeted agents for lung cancer.

  8. The Black Rock Forest Consortium: A narrative

    Science.gov (United States)

    Buzzetto-More, Nicole Antoinette

    The Black Rock Forest is a 3,785-acre wilderness area whose richly forested landscape represents the splendor of the Hudson Valley Region of New York State. Although originally intended to become the home of wealthy banker James Stillman, it was his son Ernest whose love of conservation caused him to embrace the then new and revolutionary practice of sustainable forestry and establish Black Rock in 1928. Due to Ernest Stillman's foresight, the property was protected from development and bequeathed to Harvard University following his death for the establishment of an experimental forest. The modern environmental movement in America began when the Black Rock Forest was threatened with development by Consolidated Edison, and the people of the surrounding community banded together, battling tirelessly for over 17 years to stop the degradation of this historic forest. The outcome of this crusade marked a hallmark win for the environment leaving an illustrious and inveterate legacy. The campaign resulted in the watershed legislation the National Environmental Policy Act, the formation of several environmental advocacy groups, the creation of the Council on Environmental Quality of the Executive Office of the President, as well as set a precedent for communities to initiate and win cases against major corporations in order to safeguard natural resources. In the midst of the controversy it became apparent that alternative futures for the Forest needed to be explored. As a result of a committee report and one man's vision, the idea emerged to create a consortium that would purchase and steward the Forest. With a formation that took nearly fifteen years, the Black Rock Forest Consortium was formed, a unique amalgamation of K--12 public and private schools, colleges and universities, and science and cultural centers that successfully collaborate to enhance scientific research, environmental conservation, and education. The Consortium works to bridge the gaps between learners

  9. Phase 0 clinical trials in oncology new drug development

    OpenAIRE

    Umesh Chandra Gupta; Sandeep Bhatia; Amit Garg; Amit Sharma; Vaibhav Choudhary

    2011-01-01

    Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a visi...

  10. Precision oncology: origins, optimism, and potential.

    Science.gov (United States)

    Prasad, Vinay; Fojo, Tito; Brada, Michael

    2016-02-01

    Imatinib, the first and arguably the best targeted therapy, became the springboard for developing drugs aimed at molecular targets deemed crucial to tumours. As this development unfolded, a revolution in the speed and cost of genetic sequencing occurred. The result--an armamentarium of drugs and an array of molecular targets--set the stage for precision oncology, a hypothesis that cancer treatment could be markedly improved if therapies were guided by a tumour's genomic alterations. Drawing lessons from the biological basis of cancer and recent empirical investigations, we take a more measured view of precision oncology's promise. Ultimately, the promise is not our concern, but the threshold at which we declare success. We review reports of precision oncology alongside those of precision diagnostics and novel radiotherapy approaches. Although confirmatory evidence is scarce, these interventions have been widely endorsed. We conclude that the current path will probably not be successful or, at a minimum, will have to undergo substantive adjustments before it can be successful. For the sake of patients with cancer, we hope one form of precision oncology will deliver on its promise. However, until confirmatory studies are completed, precision oncology remains unproven, and as such, a hypothesis in need of rigorous testing.

  11. Psycho-oncology: Searching for practical wisdom?

    Science.gov (United States)

    Butlin, Helen

    2015-10-01

    The debate is vigorous in psycho-oncology about whether spiritual, existential, and psychosocial are the most comprehensive terms for academic research discourses investigating meaning and purpose. A call-to-action email from the International Society of Psycho-Oncology included the term soul. The current essay highlights the historical and contemporary uses of "soul" to suggest that the re-emergent soul signifies a tacit quest for an "intangible" that seems missing in current constructs of clinical domains reflected in the vigor of the debates. It is suggested that the re-emergence of the pre-Medieval meaning(s) of the notion of soul affirms a growing need for integrative paradigms on "being human" to guide psycho-oncology practitioners and their research. As a paradigmatic example, a clinical support group entitled Soul Medicine is described as employing the term soul to open up the more marginal discourses about experiences of illness arising from philosophical reflection, arts, humanities, and spirituality within a clinical oncology context. A link between soul and wisdom is suggested for further exploration with the view that phronesis ("the virtue of practical wisdom"), an emerging concept in health professional education research, is of ultimate value to the people psycho-oncology seeks to serve. This group holds that garnering wisdom from the expertise of those living with cancer should be a central aim of our field.

  12. Midwest Superconductivity Consortium: 1995 Progress report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-01

    The mission of the Midwest Superconductivity Consortium, MISCON, is to advance the science and understanding of high Tc superconductivity. During the past year, 26 projects produced over 133 talks and 127 publications. Three Master`s Degrees and 9 Doctor`s of Philosophy Degrees were granted to students working on MISCON projects. Group activities and interactions involved 2 MISCON group meetings (held in January and July); the third MISCON Summer School held in July; 12 external speakers; 81 collaborations (with universities, industry, Federal laboratories, and foreign research centers); and 54 exchanges of samples and/or measurements. Research achievements this past year focused on understanding the effects of processing phenomena on structure-property interrelationships and the fundamental nature of transport properties in high-temp superconductors.

  13. A consortium approach to glass furnace modeling.

    Energy Technology Data Exchange (ETDEWEB)

    Chang, S.-L.; Golchert, B.; Petrick, M.

    1999-04-20

    Using computational fluid dynamics to model a glass furnace is a difficult task for any one glass company, laboratory, or university to accomplish. The task of building a computational model of the furnace requires knowledge and experience in modeling two dissimilar regimes (the combustion space and the liquid glass bath), along with the skill necessary to couple these two regimes. Also, a detailed set of experimental data is needed in order to evaluate the output of the code to ensure that the code is providing proper results. Since all these diverse skills are not present in any one research institution, a consortium was formed between Argonne National Laboratory, Purdue University, Mississippi State University, and five glass companies in order to marshal these skills into one three-year program. The objective of this program is to develop a fully coupled, validated simulation of a glass melting furnace that may be used by industry to optimize the performance of existing furnaces.

  14. Midwest Superconductivity Consortium. Progress report, 1992

    Energy Technology Data Exchange (ETDEWEB)

    Bement, A.L. Jr.

    1993-01-01

    Mission of the Midwest Superconductivity Consortium, MISCON, is to advance the science and understanding of high Tc superconductivity. Programmatic research focuses upon key materials-related problems; principally, synthesis and processing and properties limiting transport phenomena. During the past year, 26 projects produced over 133 talks and 113 publications. publications. Two Master`s Degrees and one Ph.D. were granted to students working on MISCON projects. Group activities and interactions involved two MISCON group meetings (held in July and January), twenty external speakers, 36 collaborations, 10 exchanges of samples and/or measurements, and one (1) gift of equipment from industry. Research achievements this past year expanded our understanding of processing phenomena on structure property interrelationships and the fundamental nature of transport properties in high-temperature superconductors.

  15. Consortium sandbox: building and sharing resources.

    Science.gov (United States)

    Lim, Mark D

    2014-06-25

    Some common challenges of biomedical product translation-scientific, regulatory, adoption, and reimbursement-can best be addressed by the broad sharing of resources or tools. But, such aids remain undeveloped because the undertaking requires expertise from multiple research sectors as well as validation across organizations. Biomedical resource development can benefit from directed consortia-a partnership framework that provides neutral and temporary collaborative environments for several, oftentimes competing, organizations and leverages the aggregated intellect and resources of stakeholders so as to create versatile solutions. By analyzing 369 biomedical research consortia, we tracked consortia growth around the world and gained insight into how this partnership model advances biomedical research. Our analyses suggest that research-by-consortium provides benefit to biomedical science, but the model needs further optimization before it can be fully integrated into the biomedical research pipeline.

  16. ZATPAC: a model consortium evaluates teen programs.

    Science.gov (United States)

    Owen, Kathryn; Murphy, Dana; Parsons, Chris

    2009-09-01

    How do we advance the environmental literacy of young people, support the next generation of environmental stewards and increase the diversity of the leadership of zoos and aquariums? We believe it is through ongoing evaluation of zoo and aquarium teen programming and have founded a consortium to pursue those goals. The Zoo and Aquarium Teen Program Assessment Consortium (ZATPAC) is an initiative by six of the nation's leading zoos and aquariums to strengthen institutional evaluation capacity, model a collaborative approach toward assessing the impact of youth programs, and bring additional rigor to evaluation efforts within the field of informal science education. Since its beginning in 2004, ZATPAC has researched, developed, pilot-tested and implemented a pre-post program survey instrument designed to assess teens' knowledge of environmental issues, skills and abilities to take conservation actions, self-efficacy in environmental actions, and engagement in environmentally responsible behaviors. Findings from this survey indicate that teens who join zoo/aquarium programs are already actively engaged in many conservation behaviors. After participating in the programs, teens showed a statistically significant increase in their reported knowledge of conservation and environmental issues and their abilities to research, explain, and find resources to take action on conservation issues of personal concern. Teens also showed statistically significant increases pre-program to post-program for various conservation behaviors, including "I talk with my family and/or friends about things they can do to help the animals or the environment," "I save water...," "I save energy...," "When I am shopping I look for recycled products," and "I help with projects that restore wildlife habitat."

  17. Clinical oncology and chemical thermodynamics.

    Science.gov (United States)

    Seitz, D E; Pearce, H L

    1990-01-01

    The development of oncolytic agents for cancer chemotherapy is often based on chance discovery and intensive structure modification. A mechanistic understanding of the essential biochemistry of many anticancer drugs remains elusive because of the biological complexity of drug-drug and drug-target interactions. The potential of computational science to analyze and quantify these interactions may provide a rational basis for drug modification and clinical trial design.

  18. Cats, Cancer and Comparative Oncology

    OpenAIRE

    Cannon, Claire M.

    2015-01-01

    Naturally occurring tumors in dogs are well-established models for several human cancers. Domestic cats share many of the benefits of dogs as a model (spontaneous cancers developing in an immunocompetent animal sharing the same environment as humans, shorter lifespan allowing more rapid trial completion and data collection, lack of standard of care for many cancers allowing evaluation of therapies in treatment-naïve populations), but have not been utilized to the same degree in the One Medici...

  19. Minutes of the 29. meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO). Barcelona (Spain), 12-16 September 2010; Compte-rendu de la 29e reunion de l'European Society for Therapeutic Radiology and Oncology (ESTRO). Barcelone (Espagne), 12-16 septembre 2010

    Energy Technology Data Exchange (ETDEWEB)

    Mazeron, J.J. [Service de radiotherapie oncologique, groupe hospitalier Pitie-Salpetriere, AP-HP, 47-83, boulevard de l' Hopital, 75651 Paris cedex (France)

    2011-04-15

    This document proposes overviews and comments of results of randomized trials in the field of therapeutic radiology and oncology. More precisely, it addresses therapeutic trials performed in the cases of breast cancer, endometrial cancer, prostate cancer, bladder cancer, rectal cancer, medulloblastoma, Hodgkin's lymphoma, ENT cancers, and bronchial cancers

  20. [Economic and logistical problems of radiation oncology].

    Science.gov (United States)

    Solodkiĭ, V A; Pan'shin, G A; Sotnikov, V M; Ivashin, A V

    2014-01-01

    An analysis of economic and logistical problems of radiation oncology is presented based on domestic and foreign literature. Despite the high efficacy of radiotherapy this branch of oncology is not financed enough in most countries. As a consequence, it is ubiquitously marked radiotherapy capacity deficit that does not allow to fully realize its therapeutic potential. Medical electron accelerators and related equipment have become increasingly complex and expensive and radiotherapy techniques more consuming. Even in developed countries growing waiting times for radiotherapy, not using the most modern and efficient radiotherapy technologies (image guiding, etc.) has become a daily reality. Based on these data, we assessed the prospects and possibilities of upgrading the technical base of radiation oncology in Russia including the development of hadron therapy.

  1. Robot-assisted surgery in gynecological oncology

    DEFF Research Database (Denmark)

    Kristensen, Steffen E; Mosgaard, Berit J; Rosendahl, Mikkel

    2017-01-01

    INTRODUCTION: Robot-assisted surgery has become more widespread in gynecological oncology. The purpose of this systematic review is to present current knowledge on robot-assisted surgery, and to clarify and discuss controversies that have arisen alongside the development and deployment. MATERIAL...... AND METHODS: A database search in PubMed and EMBASE was performed up until 4 March 2016. The search strategy was developed in collaboration with an information specialist, and by application of the PRISMA guidelines. Human participants and English language were the only restrictive filters applied. Selection...... was performed by screening of titles and abstracts, and by full text scrutiny. From 2001 to 2016, a total of 76 references were included. RESULTS: Robot-assisted surgery in gynecological oncology has increased, and current knowledge supports that the oncological safety is similar, compared with previous...

  2. The Servier oncology pipeline in 2017.

    Science.gov (United States)

    Therasse, Patrick; Perron, Beatrice; Novack, Sarah A; Abastado, Jean-Pierre

    2017-07-01

    Cancer is a complex, multifactorial disease that for years has been the focus of intensive research efforts to explore both the molecular and biological mechanisms involved and the development of novel agents to target these pathways. Servier is an independent French pharmaceutical company with a focus on oncology. Currently, Servier's commercial portfolio includes agents used to treat non-Hodgkin's lymphoma and metastatic colorectal cancer; Servier's oncology pipeline involves agents for the treatment of both solid and hematological tumors. The main areas of future research focus on the development of therapeutics targeting apoptosis or the active immune components involved in tumour development/maintenance. Servier intends to continue its focus on cutting-edge oncology innovation by collaborating with both industry and academia, and maintaining its strong patient-centered approach.

  3. Contemporary Trends in Radiation Oncology Resident Research.

    Science.gov (United States)

    Verma, Vivek; Burt, Lindsay; Gimotty, Phyllis A; Ojerholm, Eric

    2016-11-15

    To test the hypothesis that recent resident research productivity might be different than a decade ago, and to provide contemporary information about resident scholarly activity. We compiled a list of radiation oncology residents from the 2 most recent graduating classes (June 2014 and 2015) using the Association of Residents in Radiation Oncology annual directories. We queried the PubMed database for each resident's first-authored publications from postgraduate years (PGY) 2 through 5, plus a 3-month period after residency completion. We abstracted corresponding historical data for 2002 to 2007 from the benchmark publication by Morgan and colleagues (Int J Radiat Oncol Biol Phys 2009;74:1567-1572). We tested the null hypothesis that these 2 samples had the same distribution for number of publications using the Wilcoxon rank-sum test. We explored the association of demographic factors and publication number using multivariable zero-inflated Poisson regression. There were 334 residents publishing 659 eligible first-author publications during residency (range 0-17; interquartile range 0-3; mean 2.0; median 1). The contemporary and historical distributions were significantly different (Presearch (75%). In the historical cohort, half of all articles were published in 3 journals; in contrast, the top half of contemporary publications were spread over 10 journals-most commonly International Journal of Radiation Oncology • Biology • Physics (17%), Practical Radiation Oncology (7%), and Radiation Oncology (4%). Male gender, non-PhD status, and larger residency size were associated with higher number of publications in the multivariable analysis. We observed an increase in first-author publications during training compared with historical data from the mid-2000s. These contemporary figures may be useful to medical students considering radiation oncology, current residents, training programs, and prospective employers. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Current management of surgical oncologic emergencies.

    Directory of Open Access Journals (Sweden)

    Marianne R F Bosscher

    Full Text Available For some oncologic emergencies, surgical interventions are necessary for dissolution or temporary relieve. In the absence of guidelines, the most optimal method for decision making would be in a multidisciplinary cancer conference (MCC. In an acute setting, the opportunity for multidisciplinary discussion is often not available. In this study, the management and short term outcome of patients after surgical oncologic emergency consultation was analyzed.A prospective registration and follow up of adult patients with surgical oncologic emergencies between 01-11-2013 and 30-04-2014. The follow up period was 30 days.In total, 207 patients with surgical oncologic emergencies were included. Postoperative wound infections, malignant obstruction, and clinical deterioration due to progressive disease were the most frequent conditions for surgical oncologic emergency consultation. During the follow up period, 40% of patients underwent surgery. The median number of involved medical specialties was two. Only 30% of all patients were discussed in a MCC within 30 days after emergency consultation, and only 41% of the patients who underwent surgery were discussed in a MCC. For 79% of these patients, the surgical procedure was performed before the MCC. Mortality within 30 days was 13%.In most cases, surgery occurred without discussing the patient in a MCC, regardless of the fact that multiple medical specialties were involved in the treatment process. There is a need for prognostic aids and acute oncology pathways with structural multidisciplinary management. These will provide in faster institution of the most appropriate personalized cancer care, and prevent unnecessary investigations or invasive therapy.

  5. Genetics in neuro-oncology.

    Science.gov (United States)

    Martuza, R L

    1983-01-01

    could be identified and studied in the meningioma, the findings could be important not only in the treatment of patients with this tumor but also in the treatment of tumors of other hormonally modulated tissues such as breast and uterus. Finally, neurofibromatosis was chosen as the most common of the phakomatoses and as one which can offer significant insights into many areas of neuro-oncology. The NF gene occurs in at least two forms (VRNF, BANF), and it can be associated with virtually all of the tumors known to neurosurgeons--gliomas, neurofibromas, schwannomas, and meningiomas.(ABSTRACT TRUNCATED AT 400 WORDS)

  6. Integrated biophotonics in endoscopic oncology

    Science.gov (United States)

    Muguruma, Naoki; DaCosta, Ralph S.; Wilson, Brian C.; Marcon, Norman E.

    2009-02-01

    endoscopic diagnosis is likely to be impacted by a combination of biomarkers and technology, and 'endoscopic molecular imaging' should be defined as "visualization of molecular characteristics with endoscopy". These innovations will allow us not only to locate a tumor or dysplastic lesion but also to visualize its molecular characteristics (e.g., DNA mutations and polymorphisms, gene and/or protein expression), and the activity of specific molecules and biological processes that affect tumor behavior and/or its response to therapy. In the near future, these methods should be promising technologies that will play a central role in gastrointestinal oncology.

  7. Oncology of Reptiles: Diseases, Diagnosis, and Treatment.

    Science.gov (United States)

    Christman, Jane; Devau, Michael; Wilson-Robles, Heather; Hoppes, Sharman; Rech, Raquel; Russell, Karen E; Heatley, J Jill

    2017-01-01

    Based on necropsy review, neoplasia in reptiles has a comparable frequency to that of mammals and birds. Reptile neoplasia is now more frequently diagnosed in clinical practice based on increased use of advanced diagnostic techniques and improvements in reptilian husbandry allowing greater longevity of these species. This article reviews the current literature on neoplasia in reptiles, and focuses on advanced diagnostics and therapeutic options for reptilian patientssuffering neoplastic disease. Although most applied clinical reptile oncology is translated from dog and cat oncology, considerations specific to reptilian patients commonly encountered in clinical practice (turtles, tortoises, snakes, and lizards) are presented.

  8. Fish Oncology: Diseases, Diagnostics, and Therapeutics.

    Science.gov (United States)

    Vergneau-Grosset, Claire; Nadeau, Marie-Eve; Groff, Joseph M

    2017-01-01

    The scientific literature contains a wealth of information concerning spontaneous fish neoplasms, although ornamental fish oncology is still in its infancy. The occurrence of fish neoplasms has often been associated with oncogenic viruses and environmental insults, making them useful markers for environmental contaminants. The use of fish, including zebrafish, as models of human carcinogenesis has been developed and knowledge gained from these models may also be applied to ornamental fish, although more studies are required. This review summarizes information available about fish oncology pertaining to veterinary clinicians.

  9. Current therapies in exotic animal oncology.

    Science.gov (United States)

    Graham, Jennifer E; Kent, Michael S; Théon, Alain

    2004-09-01

    The majority of information on oncology therapies has been reported in humans, canine, and feline patients, and laboratory animals with experimentally induced tumors. A variety of treatments,including radiation therapy, chemotherapy, photodynamic therapy, and others have been used with exotic animals. There are many species of exotic pets, and anatomic differences, as well as husbandry and nutritional requirements, must be taken into account to provide optimal care. By providing a broad overview of therapies and considerations for treatment, this article is intended to provide the practitioner with an overview of approach and options when addressing oncology cases in exotic animals.

  10. The Danish Neuro-Oncology Registry

    DEFF Research Database (Denmark)

    Hansen, Steinbjørn; Nielsen, Jan; Laursen, René J

    2016-01-01

    BACKGROUND: The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database completen......BACKGROUND: The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database...

  11. [Activity of NTDs Drug-discovery Research Consortium].

    Science.gov (United States)

    Namatame, Ichiji

    2016-01-01

    Neglected tropical diseases (NTDs) are an extremely important issue facing global health care. To improve "access to health" where people are unable to access adequate medical care due to poverty and weak healthcare systems, we have established two consortiums: the NTD drug discovery research consortium, and the pediatric praziquantel consortium. The NTD drug discovery research consortium, which involves six institutions from industry, government, and academia, as well as an international non-profit organization, is committed to developing anti-protozoan active compounds for three NTDs (Leishmaniasis, Chagas disease, and African sleeping sickness). Each participating institute will contribute their efforts to accomplish the following: selection of drug targets based on information technology, and drug discovery by three different approaches (in silico drug discovery, "fragment evolution" which is a unique drug designing method of Astellas Pharma, and phenotypic screening with Astellas' compound library). The consortium has established a brand new database (Integrated Neglected Tropical Disease Database; iNTRODB), and has selected target proteins for the in silico and fragment evolution drug discovery approaches. Thus far, we have identified a number of promising compounds that inhibit the target protein, and we are currently trying to improve the anti-protozoan activity of these compounds. The pediatric praziquantel consortium was founded in July 2012 to develop and register a new praziquantel pediatric formulation for the treatment of schistosomiasis. Astellas Pharma has been a core member in this consortium since its establishment, and has provided expertise and technology in the area of pediatric formulation development and clinical development.

  12. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2010-12-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee...

  13. The experiential world of the Oncology nurse

    Directory of Open Access Journals (Sweden)

    Laetitia le Roux

    2008-03-01

    Full Text Available In her experiential world, the oncology nurse experiences unique, challenging and rewarding relationships in a multidimensional, dynamic way. The aim of this study was to describe, from her viewpoint and perspective, how she experiences and reacts to this world. Through this study the researcher wants the oncology nurse’s voice to be heard, the richness of her story acknowledged and the derived data to be applied to the benefit of the field of oncology. In-depth, unstructured phenomenological interviews provided the saturated data from which the uniqueness of the world of the oncology nurse unfolded as the uniqueness of the oncology patients and their world emerged clearly. Findings show that the oncology nurse, attending to the cancer patients and their family, experiences many different relationships. The uniqueness of the oncology nurse-patient relationship is described as unlike any other nurse-patient relationship. The challenging interpersonal relationships with management and other members of the multiprofessional team, as experienced from the perspective of the oncology nurse, are also highlighted. Furthermore, a unifying intrapersonal relationship with the self was identified. This enables the oncology nurse to be both on the giving and receiving end of the intensely emotional environment she works in, explaining, at least partly, the high job satisfaction that permeated the interviews in this study. Recommendations for nursing practice, education and research were formulated. Opsomming In haar leefwêreld ondervind onkologieverpleegkundige unieke, uitdagende en belonende verhoudinge op ‘n multidimensionele en dinamiese wyse. Die doel van hierdie studie was om ‘n beskrywing van die onkologieverpleegkundige se ervarings van en reaksie op haar leefwêreld vanuit haar oogpunt en perspektief. Deur middel van hierdie studie wil die navorser die stem van die onkologieverpleegkundige gehoor laat word, die rykdom van haar verhaal

  14. Quantitatively and qualitatively augmenting medical student knowledge of oncology and radiation oncology: an update on the impact of the oncology education initiative.

    Science.gov (United States)

    Hirsch, Ariel E; Handal, Roxane; Daniels, Janeen; Levin-Epstein, Rebecca; Denunzio, Nicholas J; Dillon, Johanne; Shaffer, Kitt; Bishop, Pauline Mulleady

    2012-02-01

    The Oncology Education Initiative was established in 2007 in an effort to advance oncology and radiation oncology education at the undergraduate level. As a continuation of the initiative, the aim of this study was to determine whether these structured didactics would continue to increase overall medical student knowledge about oncologic topics. Preclerkship and postclerkship tests examining concepts in general oncology, radiation oncology, breast cancer, and prostate cancer were administered. The 21-question, multiple-choice examination was administered at the beginning and end of the radiology clerkship, during which a 1.5-hour didactic session was given by an attending radiation oncologist. Changes in individual question responses, student responses, and overall categorical responses were analyzed. All hypothesis tests were two tailed with a significance level of .05. In the 2009-2010 academic year, 155 third-year and fourth-year students had average examination score improvements from 62% to 68.9% (P students and decreased among fourth-year students. In the successive years since its inception, the Oncology Education Initiative continues to show a significant improvement in medical students' knowledge of cancer. The initiative has also succeeded in providing radiation oncology education to all graduating medical students at the authors' institution. Dedicated oncology education in the undergraduate medical curriculum provides students with a better understanding of multidisciplinary oncology management. Copyright © 2012 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  15. SEEA SOUTHEAST CONSORTIUM FINAL TECHNICAL REPORT

    Energy Technology Data Exchange (ETDEWEB)

    Block, Timothy [Southeast Energy Efficiency Alliance; Ball, Kia [Southeast Energy Efficiency Alliance; Fournier, Ashley [Southeast Energy Efficiency Alliance

    2014-01-21

    In 2010 the Southeast Energy Efficiency Alliance (SEEA) received a $20 million Energy Efficiency and Conservation Block Grant (EECBG) under the U.S. Department of Energy’s Better Building Neighborhood Program (BBNP). This grant, funded by the American Recovery and Reinvestment Act, also included sub-grantees in 13 communities across the Southeast, known as the Southeast Consortium. The objective of this project was to establish a framework for energy efficiency retrofit programs to create models for replication across the Southeast and beyond. To achieve this goal, SEEA and its project partners focused on establishing infrastructure to develop and sustain the energy efficiency market in specific localities across the southeast. Activities included implementing minimum training standards and credentials for marketplace suppliers, educating and engaging homeowners on the benefits of energy efficiency through strategic marketing and outreach and addressing real or perceived financial barriers to investments in whole-home energy efficiency through a variety of financing mechanisms. The anticipated outcome of these activities would be best practice models for program design, marketing, financing, data collection and evaluation as well as increased market demand for energy efficiency retrofits and products. The Southeast Consortium’s programmatic impacts along with the impacts of the other BBNP grantees would further the progress towards the overall goal of energy efficiency market transformation. As the primary grantee SEEA served as the overall program administrator and provided common resources to the 13 Southeast Consortium sub-grantees including contracted services for contractor training, quality assurance testing, data collection, reporting and compliance. Sub-grantee programs were located in cities across eight states including Alabama, Florida, Georgia, Louisiana, North Carolina, South Carolina, Tennessee, Virginia and the U.S. Virgin Islands. Each sub

  16. Establishing an International Soil Modelling Consortium

    Science.gov (United States)

    Vereecken, Harry; Schnepf, Andrea; Vanderborght, Jan

    2015-04-01

    -change-feedback processes, bridge basic soil science research and management, and facilitate the communication between science and society . To meet these challenges an international community effort is required, similar to initiatives in systems biology, hydrology, and climate and crop research. We therefore propose to establish an international soil modelling consortium with the aims of 1) bringing together leading experts in modelling soil processes within all major soil disciplines, 2) addressing major scientific gaps in describing key processes and their long term impacts with respect to the different functions and ecosystem services provided by soil, 3) intercomparing soil model performance based on standardized and harmonized data sets, 4) identifying interactions with other relevant platforms related to common data formats, protocols and ontologies, 5) developing new approaches to inverse modelling, calibration, and validation of soil models, 6) integrating soil modelling expertise and state of the art knowledge on soil processes in climate, land surface, ecological, crop and contaminant models, and 7) linking process models with new observation, measurement and data evaluation technologies for mapping and characterizing soil properties across scales. Our consortium will bring together modelers and experimental soil scientists at the forefront of new technologies and approaches to characterize soils. By addressing these aims, the consortium will contribute to improve the role of soil modeling as a knowledge dissemination instrument in addressing key global issues and stimulate the development of translational research activities. This presentation will provide a compelling case for this much-needed effort, with a focus on tangible benefits to the scientific and food security communities.

  17. Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma

    Science.gov (United States)

    Gore, M E; Szczylik, C; Porta, C; Bracarda, S; Bjarnason, G A; Oudard, S; Lee, S-H; Haanen, J; Castellano, D; Vrdoljak, E; Schöffski, P; Mainwaring, P; Hawkins, R E; Crinò, L; Kim, T M; Carteni, G; Eberhardt, W E E; Zhang, K; Fly, K; Matczak, E; Lechuga, M J; Hariharan, S; Bukowski, R

    2015-01-01

    Background: We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials. Methods: Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on–2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice. Results: A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15–17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8–10.0) and 18.7 months (95% CI: 17.5–19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand–foot syndrome (each 7%). Conclusion: Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results. PMID:26086878

  18. Multi-University Southeast INIE Consortium

    Energy Technology Data Exchange (ETDEWEB)

    Ayman Hawari; Nolan Hertel; Mohamed Al-Sheikhly; Laurence Miller; Abdel-Moeze Bayoumi; Ali Haghighat; Kenneth Lewis

    2010-12-29

    2 Project Summary: The Multi-University Southeast INIE Consortium (MUSIC) was established in response to the US Department of Energy’s (DOE) Innovations in Nuclear Infrastructure and Education (INIE) program. MUSIC was established as a consortium composed of academic members and national laboratory partners. The members of MUSIC are the nuclear engineering programs and research reactors of Georgia Institute of Technology (GIT), North Carolina State University (NCSU), University of Maryland (UMD), University of South Carolina (USC), and University of Tennessee (UTK). The University of Florida (UF), and South Carolina State University (SCSU) were added to the MUSIC membership in the second year. In addition, to ensure proper coordination between the academic community and the nation’s premier research and development centers in the fields of nuclear science and engineering, MUSIC created strategic partnerships with Oak Ridge National Laboratory (ORNL) including the Spallation Neutron Source (SNS) project and the Joint Institute for Neutron Scattering (JINS), and the National Institute of Standards and Technology (NIST). A partnership was also created with the Armed Forces Radiobiology Research Institute (AFRRI) with the aim of utilizing their reactor in research if funding becomes available. Consequently, there are three university research reactors (URRs) within MUSIC, which are located at NCSU (1-MW PULSTAR), UMD (0.25-MW TRIGA) and UF (0.10-MW Argonaut), and the AFRRI reactor (1-MW TRIGA MARK F). The overall objectives of MUSIC are: a) Demonstrate that University Research Reactors (URR) can be used as modern and innovative instruments of research in the basic and applied sciences, which include applications in fundamental physics, materials science and engineering, nondestructive examination, elemental analysis, and contributions to research in the health and medical sciences, b) Establish a strong technical collaboration between the nuclear engineering

  19. Consortium for Petroleum & Natural Gas Stripper Wells

    Energy Technology Data Exchange (ETDEWEB)

    Morrison, Joel [Pennsylvania State Univ., University Park, PA (United States)

    2011-12-01

    The United States has more oil and gas wells than any other country. As of December 31, 2004, there were more than half a million producing oil wells in the United States. That is more than three times the combined total for the next three leaders: China, Canada, and Russia. The Stripper Well Consortium (SWC) is a partnership that includes domestic oil and gas producers, service and supply companies, trade associations, academia, the Department of Energy’s Strategic Center for Natural Gas and Oil (SCNGO) at the National Energy Technology Laboratory (NETL), and the New York State Energy Research and Development Authority (NYSERDA). The Consortium was established in 2000. This report serves as a final technical report for the SWC activities conducted over the May 1, 2004 to December 1, 2011 timeframe. During this timeframe, the SWC worked with 173 members in 29 states and three international countries, to focus on the development of new technologies to benefit the U.S. stripper well industry. SWC worked with NETL to develop a nationwide request-for-proposal (RFP) process to solicit proposals from the U.S. stripper well industry to develop and/or deploy new technologies that would assist small producers in improving the production performance of their stripper well operations. SWC conducted eight rounds of funding. A total of 132 proposals were received. The proposals were compiled and distributed to an industry-driven SWC executive council and program sponsors for review. Applicants were required to make a formal technical presentation to the SWC membership, executive council, and program sponsors. After reviewing the proposals and listening to the presentations, the executive council made their funding recommendations to program sponsors. A total of 64 projects were selected for funding, of which 59 were fully completed. Penn State then worked with grant awardees to issue a subcontract for their approved work. SWC organized and hosted a total of 14 meetings

  20. Merging Children's Oncology Group Data with an External Administrative Database Using Indirect Patient Identifiers: A Report from the Children's Oncology Group.

    Directory of Open Access Journals (Sweden)

    Yimei Li

    Full Text Available Clinical trials data from National Cancer Institute (NCI-funded cooperative oncology group trials could be enhanced by merging with external data sources. Merging without direct patient identifiers would provide additional patient privacy protections. We sought to develop and validate a matching algorithm that uses only indirect patient identifiers.We merged the data from two Phase III Children's Oncology Group (COG trials for de novo acute myeloid leukemia (AML with the Pediatric Health Information Systems (PHIS. We developed a stepwise matching algorithm that used indirect identifiers including treatment site, gender, birth year, birth month, enrollment year and enrollment month. Results from the stepwise algorithm were compared against the direct merge method that used date of birth, treatment site, and gender. The indirect merge algorithm was developed on AAML0531 and validated on AAML1031.Of 415 patients enrolled on the AAML0531 trial at PHIS centers, we successfully matched 378 (91.1% patients using the indirect stepwise algorithm. Comparison to the direct merge result suggested that 362 (95.7% matches identified by the indirect merge algorithm were concordant with the direct merge result. When validating the indirect stepwise algorithm using the AAML1031 trial, we successfully matched 157 out of 165 patients (95.2% and 150 (95.5% of the indirectly merged matches were concordant with the directly merged matches.These data demonstrate that patients enrolled on COG clinical trials can be successfully merged with PHIS administrative data using a stepwise algorithm based on indirect patient identifiers. The merged data sets can be used as a platform for comparative effectiveness and cost effectiveness studies.

  1. Clinical PET/MR Imaging in Oncology

    DEFF Research Database (Denmark)

    Kjær, Andreas; Torigian, Drew A.

    2016-01-01

    . The question, therefore, arises regarding what the future clinical applications of PET/MR imaging will be. In this article, the authors discuss ways in which PET/MR imaging may be used in future applications that justify the added cost, predominantly focusing on oncologic applications. The authors suggest...

  2. Ethical problems experienced by oncology nurses

    Directory of Open Access Journals (Sweden)

    Kely Regina da Luz

    2015-12-01

    Full Text Available Objective: to know the ethical problems experienced by oncology nurses. Method: descriptive and exploratory study with a qualitative approach, performed in inpatient units and in chemotherapy out-patients units that provide assistance to oncological patients in two capitals in the South region of Brazil. Eighteen nurses participated in this study, selected by snowball sampling type. For data collection, semi-structured interviews were carried out, which were recorded and transcribed, and then analyzed by thematic analysis. Results: two categories were established: when informing or not becomes a dilemma - showing the main difficulties related to oncological treatment information regarding health staff, health system, and infrastructure; to invest or not - dilemmas related to finitude - showing situations of dilemmas related to pain and confrontation with finitude. Conclusion: for the effective confrontation of the ethical problems experienced by oncology nurses to occur, it is important to invest in the training of these professionals, preparing them in an ethical and human way to act as lawyers of the patient with cancer, in a context of dilemmas related mainly to the possibility of finitude.

  3. Tobacco control policies of oncology nursing organizations.

    Science.gov (United States)

    Sarna, Linda; Bialous, Stella Aguinaga

    2004-05-01

    Nurses, the largest group of health care professionals, and the policies of nursing organizations, have tremendous potential to promote health and tobacco control. Policies addressing tobacco use have been implemented by a variety of national and international nursing organizations. This article reviews existing tobacco control policies in oncology nursing organizations.

  4. The oncological implications of immediate breast reconstruction.

    NARCIS (Netherlands)

    Knottenbelt, A.; Spauwen, P.H.M.; Wobbes, Th.

    2004-01-01

    AIMS: The timing of breast reconstruction following mastectomy has been an area of contention. The purpose of this study was to report the oncologic safety of mastectomy and immediate breast reconstruction, primarily with a tissue expander. METHODS: We offered 54 patients (58 reconstructions) an

  5. Immuno-oncology combinations:raising the tail of the survival curve

    Institute of Scientific and Technical Information of China (English)

    Samuel J Harris; Jessica Brown; Juanita Lopez; Timothy A Yap

    2016-01-01

    There have been exponential gains in immuno-oncology in recent times through the development of immune checkpoint inhibitors. Already approved by the U.S. Food and Drug Administration for advanced melanoma and non-small cell lung cancer, immune checkpoint inhibitors also appears to have significant antitumor activity in multiple other tumor types. An exciting component of immunotherapy is the durability of antitumor responses observed, with some patients achieving disease control for many years. Nevertheless, not all patients benefit, and efforts should thus now focus on improving the efficacy of immunotherapy through the use of combination approaches and predictive biomarkers of response and resistance. There are multiple potential rational combinations using an immunotherapy backbone, including existing treatments such as radiotherapy, chemotherapy or molecularly targeted agents, as well as other immunotherapeutics. The aim of such antitumor strategies will be to raise the tail on the survival curve by increasing the number of long term survivors, while managing any additive or synergistic toxicities that may arise with immunotherapy combinations. Rational trial designs based on a clear understanding of tumor biology and drug pharmacology remain paramount. This article reviews the biology underpinning immuno-oncology, discusses existing and novel immunotherapeutic combinations currently in development, the challenges of predictive biomarkers of response and resistance and the impact of immuno-oncology on early phase clinical trial design.

  6. Effects of the Consortium of Pseudomonas, Bacillus and ...

    African Journals Online (AJOL)

    Johnny

    concluded that the consortium of these bacteria can be used for the decontamination of ... affects the oil fluid properties such as gravity, viscosity and other physical parameters of crude ... by attack on the aliphatic or light aromatic fraction of oil.

  7. Regional Development and the European Consortium of Innovative Universities.

    Science.gov (United States)

    Hansen, Saskia Loer; Kokkeler, Ben; van der Sijde, P. C.

    2002-01-01

    The European Consortium of Innovative Universities is a network that shares information not just among universities but with affiliated incubators, research parks, and other regional entities. The learning network contributes to regional development.(JOW)

  8. Kinetics and characteristics of phenanthrene degradation by a microbial consortium

    Institute of Scientific and Technical Information of China (English)

    Wang Jin; Xu Hongke; An Mingquan; Yan Guiwen

    2008-01-01

    The kinetics and characteristics of phenanthrene degradation by a microbial consortium W4 isolated from Henan Oilfield were investigated. The degradation percentage of solid phenanthrene at 200 mg/L in liquid medium after 6 days of incubation was higher than 95% under the condition of 37 ℃ and 120 r/min by this microbial consortium. The degradation of phenanthrene could be fitted to a first-order kinetic model with the half-life of 1.25 days. The optimum conditions for degradation of phenanthrene by consortium W4 were as follows: temperature about 37 ℃, pH from 6.0 to 7.0 and salinity about 8.0 g/L.It was concluded that microbial consortium W4 might degrade phenanthrene via both salicylic acid and o-phthalic acid pathways by analyzing products with GC-MS.

  9. Metronomic chemotherapy regimens in oncology

    Directory of Open Access Journals (Sweden)

    M. Yu. Fedyanin

    2016-01-01

    Full Text Available Metronomic chemotherapy implies the regular use of cytotoxic agents in doses much smaller than the maximum tolerable doses for a long time. Preclinical experiments show that this treatment option has a many-sided (antiangiogenic, immunostimulating, and direct cytotoxic effect on tumor. Moreover, this approach has gained the widest acceptance in treating patients with metastatic breast cancer in clinical practice. By taking into account the high activity of angiogenesis in colon cancer progression, it is interesting to study the impact of metronomic chemotherapy regimens for this nosological entity as well. This literature review considers not only the history of metronomic chemotherapy, the mechanisms of action, and a range of drugs having an antitumor effect in the metronomic regimens, but also analyzes clinical trials of metronomic chemotherapy regimens in patients with metastatic colon cancer.

  10. Radiolabelled peptides for oncological diagnosis

    Energy Technology Data Exchange (ETDEWEB)

    Laverman, Peter; Boerman, Otto C.; Oyen, Wim J.G. [Radboud University Nijmegen Medical Centre, Department of Nuclear Medicine, Nijmegen (Netherlands); Sosabowski, Jane K. [Queen Mary University of London, Centre for Molecular Oncology, Barts Cancer Institute, London (United Kingdom)

    2012-02-15

    Radiolabelled receptor-binding peptides targeting receptors (over)expressed on tumour cells are widely under investigation for tumour diagnosis and therapy. The concept of using radiolabelled receptor-binding peptides to target receptor-expressing tissues in vivo has stimulated a large body of research in nuclear medicine. The {sup 111}In-labelled somatostatin analogue octreotide (OctreoScan trademark) is the most successful radiopeptide for tumour imaging, and was the first to be approved for diagnostic use. Based on the success of these studies, other receptor-targeting peptides such as cholecystokinin/gastrin analogues, glucagon-like peptide-1, bombesin (BN), chemokine receptor CXCR4 targeting peptides, and RGD peptides are currently under development or undergoing clinical trials. In this review, we discuss some of these peptides and their analogues, with regard to their potential for radionuclide imaging of tumours. (orig.)

  11. Technology for Innovation in Radiation Oncology.

    Science.gov (United States)

    Chetty, Indrin J; Martel, Mary K; Jaffray, David A; Benedict, Stanley H; Hahn, Stephen M; Berbeco, Ross; Deye, James; Jeraj, Robert; Kavanagh, Brian; Krishnan, Sunil; Lee, Nancy; Low, Daniel A; Mankoff, David; Marks, Lawrence B; Ollendorf, Daniel; Paganetti, Harald; Ross, Brian; Siochi, Ramon Alfredo C; Timmerman, Robert D; Wong, John W

    2015-11-01

    Radiation therapy is an effective, personalized cancer treatment that has benefited from technological advances associated with the growing ability to identify and target tumors with accuracy and precision. Given that these advances have played a central role in the success of radiation therapy as a major component of comprehensive cancer care, the American Society for Radiation Oncology (ASTRO), the American Association of Physicists in Medicine (AAPM), and the National Cancer Institute (NCI) sponsored a workshop entitled "Technology for Innovation in Radiation Oncology," which took place at the National Institutes of Health (NIH) in Bethesda, Maryland, on June 13 and 14, 2013. The purpose of this workshop was to discuss emerging technology for the field and to recognize areas for greater research investment. Expert clinicians and scientists discussed innovative technology in radiation oncology, in particular as to how these technologies are being developed and translated to clinical practice in the face of current and future challenges and opportunities. Technologies encompassed topics in functional imaging, treatment devices, nanotechnology, and information technology. The technical, quality, and safety performance of these technologies were also considered. A major theme of the workshop was the growing importance of innovation in the domain of process automation and oncology informatics. The technologically advanced nature of radiation therapy treatments predisposes radiation oncology research teams to take on informatics research initiatives. In addition, the discussion on technology development was balanced with a parallel conversation regarding the need for evidence of efficacy and effectiveness. The linkage between the need for evidence and the efforts in informatics research was clearly identified as synergistic.

  12. AGRICOH: A Consortium of Agricultural Cohorts

    Directory of Open Access Journals (Sweden)

    Shelia H. Zahm

    2011-04-01

    Full Text Available AGRICOH is a recently formed consortium of agricultural cohort studies involving 22 cohorts from nine countries in five continents: South Africa (1, Canada (3, Costa Rica (2, USA (6, Republic of Korea (1, New Zealand (2, Denmark (1, France (3 and Norway (3. The aim of AGRICOH, initiated by the US National Cancer Institute (NCI and coordinated by the International Agency for Research on Cancer (IARC, is to promote and sustain collaboration and pooling of data to investigate the association between a wide range of agricultural exposures and a wide range of health outcomes, with a particular focus on associations that cannot easily be addressed in individual studies because of rare exposures (e.g., use of infrequently applied chemicals or relatively rare outcomes (e.g., certain types of cancer, neurologic and auto-immune diseases. To facilitate future projects the need for data harmonization of selected variables is required and is underway. Altogether, AGRICOH provides excellent opportunities for studying cancer, respiratory, neurologic, and auto-immune diseases as well as reproductive and allergic disorders, injuries and overall mortality in association with a wide array of exposures, prominent among these the application of pesticides.

  13. [Japan Spastic Paraplegia Research Consortium (JASPAC)].

    Science.gov (United States)

    Takiyama, Yoshihisa

    2014-10-01

    Japan Spastic Paraplegia Research Consortium (JASPAC), a nationwide clinical and genetic survey of patients with hereditary spastic paraplegia (HSP), was started in 2006 as a project of the Research Committee for Ataxic Diseases of the Ministry of Health, Labor, and Welfare, Japan. To date (April 4, 2014), 448 indexed patients with HSP have been registered from 46 prefectures in Japan. We are now performing molecular testing of the HSP patients using Sanger sequencing (SPG4, SPG11, SPG31, and ARSACS), comparative genomic hybridization (CGH) array (SPG1, 2, 3A, 4, 5, 6, 7, 8, 10, 11, 13, 15, 17, 20, 21, 31, 33, 39, 42, ABCD1, alsin, and ARSACS), and resequencing microarray (SPG1, 2, 3A, 4, 5, 6, 7, 8, 10, 11, 13, 17, 20, 21, 31, 33, and ABCD1). In 206 Japanese families with autosomal dominant HSP, SPG4 was the most common form, accounting for 38%, followed by SPG3A (5%), SPG31 (5%), SPG10 (2%), and SPG8 (1%). In 88 patients with autosomal recessive HSP, although SPG11 was the most common form, accounting for 6%, most showed significant genetic heterogeneity. The results of molecular testing will be applicable to patients in terms of improved positive diagnosis, follow-up, and genetic counseling. JASPAC will contribute to elucidating the molecular mechanisms underlying HSP, and will facilitate the development of better treatments for HSP.

  14. Astroparticle Physics European Consortium Town Meeting Conference

    CERN Document Server

    2016-01-01

    The Astroparticle Physics European Consortium (APPEC) invites you to a town meeting at the Grand Amphithéatre de Sorbonne in Paris on the 6th and 7th April 2016 to discuss an update of the 2011 APPEC Astroparticle Physics roadmap, to be published in September 2016. In 2014 APPEC decided to launch an update of the 2011 Roadmap, transforming it to a “resource aware” roadmap. The intention was to gauge the financial impact of the beginnings of operation of the large global scale observatories put forward in the previous roadmap and to examine the possibilities of international coordination of future global initiatives. The APPEC Scientific Advisory Committee examined the field and prepared a set of recommendations. Based on these recommendations, the APPEC General Assembly drafted a set of “considerations” to be published by end of February 2016 and be debated in an open dialogue with the community, through the web page but primarily at the town meeting of 6-7 April. Based on this debate the final re...

  15. Outcomes of hospitalized neutropenic oncology patients with Pseudomonas aeruginosa bloodstream infections: focus on oral fluoroquinolone conversion.

    Science.gov (United States)

    Yan, Lily Z; Herrington, Jon D

    2016-08-01

    Pseudomonas aeruginosa bacteremia is a major cause of morbidity and mortality, especially in neutropenic oncology patients. Few studies have been published in the last decade on treatment outcomes of neutropenic oncology patients with Pseudomonas aeruginosa bacteremia. In addition, there is a lack of data addressing the role of oral fluoroquinolones in this patient setting. A retrospective chart review from 1999 to 2013 was conducted at a large academic medical center in neutropenic oncology patients with documented Pseudomonas aeruginosa bacteremia, who were initially treated with intravenous anti-pseudomonal antibiotics and then converted to an oral anti-pseudomonal fluoroquinolone. Patients were evaluated for the rate of cure and for the time from onset of intravenous antibiotic therapy to conversion to oral fluoroquinolones. Twenty-nine patients with Pseudomonas aeruginosa bacteremia were evaluated. The median absolute neutrophil count at the time of the first positive blood culture was 50 cells/mm(3), and the median duration of time below an absolute neutrophil count of 1000 cells/mm(3) was five days. The change to oral fluoroquinolones occurred at a median (range) of six (2-18) days after initiation of intravenous antibiotics and at a median absolute neutrophil count of 2610 (110-24790) cells/mm(3). The initial cure was 93.1%, while ultimate cure was 91.7%. Converting to oral fluoroquinolones after initial intravenous antibiotic therapy for Pseudomonas aeruginosa bacteremia in clinically stable neutropenic oncology patients appears to achieve successful outcomes. However, prospective trials are needed to validate these results in neutropenic oncology patients with Pseudomonas aeruginosa bacteremia who are converted to oral fluoroquinolones. © The Author(s) 2015.

  16. Biodeterioration studies of thermoplastics in nature using indigenous bacterial consortium

    Directory of Open Access Journals (Sweden)

    Mohd. Shahbaz Anwar

    2013-06-01

    Full Text Available Thermoplastics, poly vinyl chloride and low-density polyethylene were treated in the presence of indigenously developed bacterial consortium in laboratory and natural conditions. The consortium was developed using four bacteria, selected on the basis of utilization of PVC as primary carbon source, namely P. otitidis, B. aerius, B. cereus and A. pedis isolated from the plastic waste disposal sites in Northern India. The comparative in-vitro treatment studies as revealed by the spectral and thermal data, illustrated the relatively better biodegradation potential of developed consortium for PVC than the LDPE. Further, the progressive treatments of both the thermoplastics were conducted for three months under natural conditions. For this purpose, bioformulation of consortium was prepared and characterized for the viability up to 70 days of storage at 25±1ºC. The consortium treated polymer samples were monitored through SEM and FT-IR spectroscopy. Analytical data revealed the biodeterioration potential of the developed consortium for PVC and LDPE, which could help in disposing the plastic waste.

  17. CT perfusion of the liver: principles and applications in oncology.

    Science.gov (United States)

    Kim, Se Hyung; Kamaya, Aya; Willmann, Jürgen K

    2014-08-01

    With the introduction of molecularly targeted chemotherapeutics, there is an increasing need for defining new response criteria for therapeutic success because use of morphologic imaging alone may not fully assess tumor response. Computed tomographic (CT) perfusion imaging of the liver provides functional information about the microcirculation of normal parenchyma and focal liver lesions and is a promising technique for assessing the efficacy of various anticancer treatments. CT perfusion also shows promising results for diagnosing primary or metastatic tumors, for predicting early response to anticancer treatments, and for monitoring tumor recurrence after therapy. Many of the limitations of early CT perfusion studies performed in the liver, such as limited coverage, motion artifacts, and high radiation dose of CT, are being addressed by recent technical advances. These include a wide area detector with or without volumetric spiral or shuttle modes, motion correction algorithms, and new CT reconstruction technologies such as iterative algorithms. Although several issues related to perfusion imaging-such as paucity of large multicenter trials, limited accessibility of perfusion software, and lack of standardization in methods-remain unsolved, CT perfusion has now reached technical maturity, allowing for its use in assessing tumor vascularity in larger-scale prospective clinical trials. In this review, basic principles, current acquisition protocols, and pharmacokinetic models used for CT perfusion imaging of the liver are described. Various oncologic applications of CT perfusion of the liver are discussed and current challenges, as well as possible solutions, for CT perfusion are presented.

  18. The Challenges of Precision Oncology Drug Development and Implementation.

    Science.gov (United States)

    Hollingsworth, Simon J; Biankin, Andrew V

    2015-01-01

    The drivers of precision medicine are clear: for patients (and physicians)--more options, durable clinical benefit, reduced exposure to non-effective drugs and potential to leverage current scientific and technological advances; for the pharmaceutical industry--the potential to tackle core challenges in discovering and developing better and more efficacious medicines, to reduce rates of attrition in drug development and to reduce development costs; for healthcare systems and payers--improved efficiency through the provision of effective care and avoiding ineffective treatments. Oncology has been at the vanguard, the improvements gained in patient survival notable. However, the increasing number of molecular subgroups requires an equally increasing number (and new generation) of highly selective agents targeting inevitably lower incidence molecular segments. Innovative trial designs (umbrella/basket studies) are emerging as a patient-centric approach to drug development, and the rise in public-private partnerships, cross-industry, government and non-profit sector collaborations is enabling implementation of complex clinical trial designs. This poses significant challenges for healthcare systems and regulatory approval. Further substantial evolution of policy and processes, particularly regulatory requirements for approval for new therapeutics, are required.

  19. Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report.

    Science.gov (United States)

    Rosenthal, Eben L; Warram, Jason M; de Boer, Esther; Basilion, James P; Biel, Merrill A; Bogyo, Matthew; Bouvet, Michael; Brigman, Brian E; Colson, Yolonda L; DeMeester, Steven R; Gurtner, Geoffrey C; Ishizawa, Takeaki; Jacobs, Paula M; Keereweer, Stijn; Liao, Joseph C; Nguyen, Quyen T; Olson, James M; Paulsen, Keith D; Rieves, Dwaine; Sumer, Baran D; Tweedle, Michael F; Vahrmeijer, Alexander L; Weichert, Jamey P; Wilson, Brian C; Zenn, Michael R; Zinn, Kurt R; van Dam, Gooitzen M

    2016-01-01

    Navigation with fluorescence guidance has emerged in the last decade as a promising strategy to improve the efficacy of oncologic surgery. To achieve routine clinical use, the onus is on the surgical community to objectively assess the value of this technique. This assessment may facilitate both Food and Drug Administration approval of new optical imaging agents and reimbursement for the imaging procedures. It is critical to characterize fluorescence-guided procedural benefits over existing practices and to elucidate both the costs and the safety risks. This report is the result of a meeting of the International Society of Image Guided Surgery (www.isigs.org) on February 6, 2015, in Miami, Florida, and reflects a consensus of the participants' opinions. Our objective was to critically evaluate the imaging platform technology and optical imaging agents and to make recommendations for successful clinical trial development of this highly promising approach in oncologic surgery.

  20. Pyruvate Dehydrogenase Kinase as a Novel Therapeutic Target in Oncology

    Directory of Open Access Journals (Sweden)

    Gopinath eSutendra

    2013-03-01

    Full Text Available Current drug development in oncology is non-selective as it typically focuses on pathways essential for the survival of all dividing cells. The unique metabolic profile of cancer, which is characterized by increased glycolysis and suppressed mitochondrial glucose oxidation provides cancer cells with a proliferative advantage, conducive with apoptosis resistance and even increased angiogenesis. Recent evidence suggests that targeting the cancer-specific metabolic and mitochondrial remodeling may offer selectivity in cancer treatment. Pyruvate dehydrogenase kinase (PDK is a mitochondrial enzyme that is activated in a variety of cancers and results in the selective inhibition of pyruvate dehydrogenase (PDH, a complex of enzymes that converts cytosolic pyruvate to mitochondrial acetyl-CoA, the substrate for the Krebs’ cycle. Inhibition of PDK with either small interfering RNAs or the orphan drug dichloroacetate (DCA shifts the metabolism of cancer cells from glycolysis to glucose oxidation and reverses the suppression of mitochondria-dependent apoptosis. In addition, this therapeutic strategy increases the production of diffusible Krebs’ cycle intermediates and mitochondria-derived reactive oxygen species (mROS, activating p53 or inhibiting pro-proliferative and pro-angiogenic transcription factors like nuclear factor of activated T-cells (NFAT and hypoxia-inducible factor 1α (HIF1α. These effects result in decreased tumor growth and angiogenesis in a variety of cancers with high selectivity. In a small but mechanistic clinical trial in patients with glioblastoma, a highly aggressive and vascular form of brain cancer, DCA decreased tumor angiogenesis and tumor growth, suggesting that metabolic targeting therapies can be translated directly to patients. Therefore, reversing the mitochondrial suppression with metabolic-modulating drugs, like PDK inhibitors holds promise in the rapidly expanding field of metabolic oncology.

  1. Oncologic safety of conservative mastectomy in the therapeutic setting

    Science.gov (United States)

    Dumitru, Dorin; Malata, Charles M.

    2016-01-01

    Conservative mastectomy is a form of nipple-sparing mastectomy which is emerging as a surgical option for selected breast cancer patients. This technique differs from subcutaneous mastectomy which is well established as a technique for risk reduction but leaves behind a finite remnant of retro-areolar breast tissue. Clinical trials have confirmed the efficacy and safety of breast conservation therapy for smaller localised breast tumors whereby a variable amount of surrounding normal tissue is excised with administration of breast radiotherapy post-operatively. Conservative mastectomy aims to remove all breast tissue with dissection continued into the core of the nipple. However, the indication for conservative mastectomy remains to be defined but generally includes tumors of modest size located at least 2 cm away from the nipple. Patients undergoing conservative mastectomy do not necessarily receive adjuvant radiotherapy and this may only be intra-operative irradiation of the nipple-areola complex (NAC). Preservation of the NAC as part of a skin-sparing mastectomy in patients who might otherwise require standard mastectomy is of unproven safety from an oncologic perspective but is associated with enhanced cosmetic outcomes and quality-of-life. The advent of conservative mastectomy has coincided with a trend for “maximal surgery” with bilateral extirpation of all breast tissue in conjunction with immediate breast reconstruction. It is essential there is no compromise of local recurrence and survival in terms of ipsilateral breast cancer treatment. Further studies are required to clarify the indications for conservative mastectomy and confirm oncologic equivalence to either wide local excision and breast irradiation or conventional/skin-sparing mastectomy with sacrifice of the nipple areola complex. PMID:26855907

  2. Enrichment strategy to select functional consortium from mixed cultures: Consortium from rumen liquor for simultaneous cellulose degradation and hydrogen production

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Aijie; Ren, Nanqi [State Key Lab of Urban Water Resource and Environment, Harbin Institute of Technology, Harbin 150090 (China); School of Environmental and Municipal Engineering, Harbin Institute of Technology, Harbin 150090 (China); Gao, Lingfang; Xu, Jifei; Liu, Chong; Lee, Duu-Jong [School of Environmental and Municipal Engineering, Harbin Institute of Technology, Harbin 150090 (China)

    2010-12-15

    Strain isolation using conventional roll tube/plating technique is time consuming and is able to culture in vitro only a small fraction of existing microbes in a natural microflora. This paper proposed a simple and rapid method to select the as-simple-as-possible biological consortium by serially diluting the original mixed culture. The diluted which remains, while the one diluted in serial loses the target function, is defined as the functional consortium of the original mixed culture. Since the microbial structure and the reaction pathway incorporated with the functional consortium is much simpler than its original mother liquor, detailed analysis on the strain interaction is possible without the risk of losing key functional strains as often caused from conventional isolation method. The rumen liquor that can degrade cellulose and produce hydrogen is used as a demonstration example. A ''rumen cellulose-degrading bacterial consortium'' (RCBC) was identified using the proposed enrichment strategy. (author)

  3. Lung Cancer Clinical Trials: Advances in Immunotherapy

    Science.gov (United States)

    New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.

  4. Adolescent and Young Adult (AYA) Oncology in the United States: A Specialty in Its Late Adolescence.

    Science.gov (United States)

    Shaw, Peter H; Reed, Damon R; Yeager, Nicholas; Zebrack, Bradley; Castellino, Sharon M; Bleyer, Archie

    2015-04-01

    Over the last 30 years, it has become apparent that oncology patients ages 15 to 39 have not reaped the same rewards of improved survival that we have seen in younger and older patients. As a result, in 2006 the Adolescent and Young Adult (AYA) Oncology Progress Review Group convened and examined the factors that impact the care of the 70,000 new cases per year (approximately 7% of all new cases) in the United States and published their findings. The reasons for inferior survival gains are of course multiple and include the settings in which patients are cared for, clinical trial enrollment, insurance coverage, varied treatment of sarcomas, varied treatment of acute lymphoblastic leukemia, the psychosocial impact of cancer and cancer survivorship. A new area of a yet-to-be completely defined subspecialty was born out of this meeting: AYA oncology. As a medical community we realized that these patients do not fit neatly into the pediatric nor adult world and, therefore, require a unique approach which many individuals, oncology centers, advocacy groups, and cooperative trial groups have started to address. This group of dedicated providers and advocates has made strides but there is still much work to be done on the local, national, and international level to make up for shortcomings in the medical system and improve outcomes. We review key components of AYA cancer care in 2015 that all providers should be aware of, how far we have come, where this movement is headed, and the obstacles that continue to stand in the way of better cure rates and quality of life after cure for this unique group of patients. Like an adolescent maturing into adulthood, this movement has learned from the past and is focused on moving into the future to achieve its goals.

  5. Cats, Cancer and Comparative Oncology

    Directory of Open Access Journals (Sweden)

    Claire M. Cannon

    2015-06-01

    Full Text Available Naturally occurring tumors in dogs are well-established models for several human cancers. Domestic cats share many of the benefits of dogs as a model (spontaneous cancers developing in an immunocompetent animal sharing the same environment as humans, shorter lifespan allowing more rapid trial completion and data collection, lack of standard of care for many cancers allowing evaluation of therapies in treatment-naïve populations, but have not been utilized to the same degree in the One Medicine approach to cancer. There are both challenges and opportunities in feline compared to canine models. This review will discuss three specific tumor types where cats may offer insights into human cancers. Feline oral squamous cell carcinoma is common, shares both clinical and molecular features with human head and neck cancer and is an attractive model for evaluating new therapies. Feline mammary tumors are usually malignant and aggressive, with the ‘triple-negative’ phenotype being more common than in humans, offering an enriched population in which to examine potential targets and treatments. Finally, although there is not an exact corollary in humans, feline injection site sarcoma may be a model for inflammation-driven tumorigenesis, offering opportunities for studying variations in individual susceptibility as well as preventative and therapeutic strategies.

  6. Challenging issues in pediatric oncology

    Science.gov (United States)

    Pui, Ching-Hon; Gajjar, Amar J.; Kane, Javier R.; Qaddoumi, Ibrahim A.; Pappo, Alberto S.

    2011-01-01

    Improvements in protocol-driven clinical trials and supportive care for children and adolescents with cancer have reduced mortality rates by more than 50% over the past three decades. Overall, the 5-year survival rate for pediatric cancer patients has increased to approximately 80%. Recognition of the biological heterogeneity within specific subtypes of cancer, the discovery of genetic lesions that drive malignant transformation and cancer progression, and improved understanding of the basis of drug resistance will undoubtedly catalyze further advances in risk-directed treatments and the development of targeted therapies, boosting the cure rates further. Emerging new treatments include novel formulations of existing chemotherapeutic agents, monoclonal antibodies against cancer-associated antigens, and molecular therapies that target genetic lesions and their associated signaling pathways. Recent findings that link pharmacogenomic variations with drug exposure, adverse effects, and efficacy should accelerate efforts to develop personalized therapy for individual patients. Finally, palliative care should be included as an essential part of cancer management to prevent and relieve the suffering and to improve the quality of life of patients and their families. PMID:21709698

  7. Antioxidant activity of the probiotic consortium in vitro

    Directory of Open Access Journals (Sweden)

    Saule Saduakhasova

    2014-01-01

    Full Text Available Introduction: Available evidence suggests that probiotics have different biological functions that depend on several mechanisms, such as antioxidant and DNA-protective activities. The probiotic consortium includes bacterial cultures such as Streptococcus thermophilus, Lactococcus lactis, Lactobacillus plantarum, and other bacterial cultures isolated from traditional Kazakh dairy products (ayran, kumys, shubat, and healthy clinical material. The aim of this study was to investigate the total antioxidant activity of the consortium of probiotic bacteria and to determine the activity of superoxide dismutase, glutathione reductase, and DNA-protective action. Material and methods: In vitro comet assay was used to determine the antigenotoxicity of the probiotic consortium. Total antioxidant activity was determined using a method of analysis with Trolox as the equivalent. The analysis method of superoxide dismutase activity assesses the inhibition rate of the nitroblue tetrazolium reduction to formazan by superoxide dismutase. Determination of glutathione reductase activity is based on the measurement of the NADPH oxidation speed. Results: A significantly high level of the total antioxidant activity of the probiotic consortium intact cells (15.3 mM/ml was observed whereas the activity index of  lysate  was 11.1 mM/ml. The superoxide dismutase activity of probiotic consortium lysate was evaluated, with values that peaked at 0.24 U/mg protein. The superoxide dismutase activity of the consortium was lower in comparison to L.fernentum E-3 and L.fernentum E-18 cultures with values of 0.85 U/mg and 0.76 U/mg protein, respectively. SOD activity of probiotic consortium whole cells was not observed, which is typical for lactic acid bacteria. Glutathione reductase plays an important role in the optimal protection from oxidative stress. Glutathione reductase activity of the studied probiotic consortium was low; moreover, the activity of the lysate was two times

  8. [Erythropoiesis stimulating agents: Literature review of uses and indications in advanced oncological and non-oncological disease in the elderly].

    Science.gov (United States)

    Fernandez Letamendi, Nieves; Fernandez Letamendi, Teresa; Montañes Gracia, M Angeles; Recasens Flores, Valle

    2017-08-02

    The aim of this article is to review possible indications and controversies about the most frequent uses of ESAs in the treatment of anaemia in elderly patients with oncological and non-oncological diseases. Using PubMed a systematic review was carried out on articles published from 1985 to September 2016, as well as a review of the main Spanish, European, and American consensus guidelines on each of the following diseases in which could pose the treatment of anaemia associated with ESA. A review was also carried out on the main Spanish, European and American consensus guidelines regarding the management of anaemia related to the diseases outlined in this article. It was found that there are limitations of its use in elderly patients with advanced disease, mainly due to the lack of uniformity and consensus in the recommendations, and the absence of large-scale prospective trials to determine the effectiveness of ESA in this population. There seems to be consensus in the use in patients with advanced chronic kidney disease, individualised in patients with non-myeloid cancer on treatment without curative intent, and in patients with myelodysplastic syndrome, still responders to space transfusional support. In the remainder, it should be individualised, since the risk of mortality and cardioembolic morbidity is clearly increased. It should not be the solution to treat anaemia, in cases of urgency or short-term transfusional need, which are often present in these patients. Copyright © 2017 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. The National Astronomy Consortium (NAC) - Overview

    Science.gov (United States)

    Sheth, Kartik; Mills, Elisabeth A. C.; Hooper, Eric; National Astronomy Consortium

    2015-01-01

    The National Astronomy Consortium (NAC; see https://sites.google.com/site/nraonac/) is a growing national partnership between majority and minority universities and institutions with the goal of increasing the numbers of under-represented minorities and students who might otherwise be overlooked by the traditional academic pipeline into STEM, or related, careers. The NAC model is based on the successful 'Posse Foundation' model for undergraduate success and incorporates all its major components: pre-training of cohorts to prepare them for the research experience, joint weekly cohort activities throughout the research summer, peer- and multiple mentoring, weekly discussion of various aspects of professional and career development, continued engagement of students in science after return to home institution and lifelong mentoring. The mentors also form a cohort, exchanging information and learning from each other. With its partner institutions, the NAC aims to build a complete pipeline from undergraduate through career for the next generation of scientists and engineers. Our annual goal is to create two to three cohorts of four to five students at each site (currently NRAO-Charlottesville, NRAO-Socorro and U. Wisconsin - Madison). Recruitment occurs in the fall semester with seminars and colloquia in partnership with faculty at the minority serving institutions and the GRAD-MAP program at the University of Maryland. In this talk we describe in detail all the components of the NAC and report on our progress. We are keen to interact and partner with new universities and institutions and encourage them to contact the NAC at nac4stem@googlegroups.com.

  10. Treatment of cachexia in oncology

    Directory of Open Access Journals (Sweden)

    E M Tazi

    2010-01-01

    Full Text Available Background: Cachexia is a complex metabolic syndrome associated with many chronic or end-stage diseases, especially cancer, and is characterized by loss of muscle with or without loss of fat mass. The management of cachexia is a complex challenge that should address the different causes underlying this clinical event with an integrated or multimodal treatment approach targeting the different factors involved in its pathophysiology. Aims and Objectives : The purpose of this article was to review the current medical treatment of cancer-related cachexia, in particular focusing on combination therapy and ongoing research. Results : Among the treatments proposed in the literature for cancer-related cachexia, some proved to be ineffective, namely, cyproheptadine, hydrazine, metoclopramide, and pentoxifylline. Among effective treatments, progestagens are currently considered the best available treatment option for cancer-related cachexia, and they are the only drugs approved in Europe. Drugs with a strong rationale that have failed or have not shown univocal results in clinical trials so far include eicosapentaenoic acid, cannabinoids, bortezomib, and anti-TNF-alpha MoAb. Several emerging drugs have shown promising results but are still under clinical investigation (thalidomide, selective cox-2 inhibitors, ghrelin mimetics, insulin, oxandrolone, and olanzapine. Conclusions : To date, despite several years of coordinated efforts in basic and clinical research, practice guidelines for the prevention and treatment of cancer-related muscle wasting are lacking, mainly because of the multifactorial pathogenesis of the syndrome. From all the data presented, one can speculate that one single therapy may not be completely successful in the treatment of cachexia. From this point of view, treatments involving different combinations are more likely to be successful.

  11. R-IDEAL: A Framework for Systematic Clinical Evaluation of Technical Innovations in Radiation Oncology.

    Science.gov (United States)

    Verkooijen, Helena M; Kerkmeijer, Linda G W; Fuller, Clifton D; Huddart, Robbert; Faivre-Finn, Corinne; Verheij, Marcel; Mook, Stella; Sahgal, Arjun; Hall, Emma; Schultz, Chris

    2017-01-01

    The pace of innovation in radiation oncology is high and the window of opportunity for evaluation narrow. Financial incentives, industry pressure, and patients' demand for high-tech treatments have led to widespread implementation of innovations before, or even without, robust evidence of improved outcomes has been generated. The standard phase I-IV framework for drug evaluation is not the most efficient and desirable framework for assessment of technological innovations. In order to provide a standard assessment methodology for clinical evaluation of innovations in radiotherapy, we adapted the surgical IDEAL framework to fit the radiation oncology setting. Like surgery, clinical evaluation of innovations in radiation oncology is complicated by continuous technical development, team and operator dependence, and differences in quality control. Contrary to surgery, radiotherapy innovations may be used in various ways, e.g., at different tumor sites and with different aims, such as radiation volume reduction and dose escalation. Also, the effect of radiation treatment can be modeled, allowing better prediction of potential benefits and improved patient selection. Key distinctive features of R-IDEAL include the important role of predicate and modeling studies (Stage 0), randomization at an early stage in the development of the technology, and long-term follow-up for late toxicity. We implemented R-IDEAL for clinical evaluation of a recent innovation in radiation oncology, the MRI-guided linear accelerator (MR-Linac). MR-Linac combines a radiotherapy linear accelerator with a 1.5-T MRI, aiming for improved targeting, dose escalation, and margin reduction, and is expected to increase the use of hypofractionation, improve tumor control, leading to higher cure rates and less toxicity. An international consortium, with participants from seven large cancer institutes from Europe and North America, has adopted the R-IDEAL framework to work toward coordinated, evidence

  12. Mind-body therapies in integrative oncology.

    Science.gov (United States)

    Elkins, Gary; Fisher, William; Johnson, Aimee

    2010-12-01

    There is growing interest in mind-body therapies as adjuncts to mainstream cancer treatment, and an increasing number of patients turn to these interventions for the control of emotional stress associated with cancer. Increased research funding has enabled many such interventions to be evaluated for their efficacy, including studies of mind-body interventions to reduce pain, anxiety, insomnia, anticipatory, and treatment-related nauseas, hot flashes, and improved mood. Mind-body treatments evaluated for their utility in oncology include relaxation therapies, biofeedback, meditation and hypnosis, yoga, art and music therapy, tai chi, and qigong. Although studies are not always methodologically sound and results mixed, a growing number of well-designed studies provide convincing evidence that mind-body techniques are beneficial adjuncts to cancer treatment. The evidence is sufficient to recommend further investigation and adoption of these techniques in mainstream oncology care.

  13. Neuro-oncology of CNS tumors

    Energy Technology Data Exchange (ETDEWEB)

    Tonn, J.C. [Klinikum Grosshadern, Muenchen (Germany). Dept. of Neurosurgery; Westphal, M. [Universitaetskrankenhaus Eppendorf, Hamburg (Germany). Neurochirurgische Klinik; Rutka, J.T. [Toronto Univ. Hospital for Sick Children, ON (Canada). Div. of Neurosurgery; Grossmann, S.A. (eds.) [Johns Hopkins Oncology Center Neuro-Oncology, Baltimore, MD (United States)

    2006-07-01

    Diagnosis and treatment modalities for neuro-oncologic diseases have made considerable advances in recent years. There is hardly a segment of the field of solid tumours that is experiencing such dynamic development with regard to basic scientific findings and clinical results. In the present book the world's leading experts have compiled the current practice-relevant knowledge of neuro-oncologic diseases. The book's clear structure and the uniform presentation of all chapters make this volume a valuable reference, especially for practice-oriented activities, allowing swift access to information about current treatment standards. Hence it will be of great value to both clinicians and researchers. (orig.)

  14. Radiation oncology a physicist's-eye view

    CERN Document Server

    Goitein, Michael

    2007-01-01

    Radiation Oncology: A Physicist's-Eye View was written for both physicists and medical oncologists with the aim of helping them approach the use of radiation in the treatment of cancer with understanding, confidence, and imagination. The book will let practitioners in one field understand the problems of, and find solutions for, practitioners in the other. It will help them to know "why" certain approaches are fruitful while, at the same time, encouraging them to ask the question "Why not?" in the face of assertions that some proposal of theirs is impractical, unreasonable, or impossible. Unlike a textbook, formal and complete developments of the topics are not among the goals. Instead, the reader will develop a foundation for understanding what the author has found to be matters of importance in radiation oncology during over thirty years of experience. Presentations cover, in largely non-technical language, the principal physical and biological aspects of radiation treatment and address practical clinical c...

  15. Value: a framework for radiation oncology.

    Science.gov (United States)

    Teckie, Sewit; McCloskey, Susan A; Steinberg, Michael L

    2014-09-10

    In the current health care system, high costs without proportional improvements in quality or outcome have prompted widespread calls for change in how we deliver and pay for care. Value-based health care delivery models have been proposed. Multiple impediments exist to achieving value, including misaligned patient and provider incentives, information asymmetries, convoluted and opaque cost structures, and cultural attitudes toward cancer treatment. Radiation oncology as a specialty has recently become a focus of the value discussion. Escalating costs secondary to rapidly evolving technologies, safety breaches, and variable, nonstandardized structures and processes of delivering care have garnered attention. In response, we present a framework for the value discussion in radiation oncology and identify approaches for attaining value, including economic and structural models, process improvements, outcome measurement, and cost assessment.

  16. Resilience and family of oncological patients

    Directory of Open Access Journals (Sweden)

    María Elena Garassi

    2015-09-01

    Full Text Available Resilience like ability to overcome adversity and even learn and get out “strengthened” them has become, in the last decade, the focus of many studies throughout the life cycle and in different cultures. On the other hand, oncological disease was introduced globally in a high percentage of the population requiring labor and health team including psychologists for coping on the part of the patient and their family members. The authors cited in the course of this article refer to the importance of developing resilience at the personal, family and cultural level, started with the presence of trust relationships, cultivating positive emotions, the acceptance of different cycles of life and belief in a just world. These promoting resilience factors are the springs that allow the experience of oncological disease and even death and mourning as opportunities to generate personal and familiar learning. 

  17. The National Centre for Oncological Hadrontherapy (CNAO): Status and perspectives.

    Science.gov (United States)

    Rossi, Sandro

    2015-06-01

    The National Centre for Oncological Hadrontherapy (CNAO, sited in Pavia, Italy) completed at the end of 2013 the clinical trial phase achieving the CE label from the notified body of the Italian Health Ministry and obtained the authorisation to treat patients within the national health system. Nowadays more than 400 patients completed the treatments, two thirds of them with carbon ions, and recently started the treatment of pathologies located within moving organs. For the first time in the world carbon ions delivered with active scanning, coupled with breathing synchronisation and rescanning modalities have been applied to treat patients affected by tumours of the liver and by pancreatic cancers. The path to reach the final CE label required a wide-ranging experimental activity that went through dosimetry measurements of the hadron beams, in-vitro and in-vivo radiobiology essays and treatments of 150 patients, all enrolled in one of the 23 clinical trials approved by the Ethical Committee of CNAO and then authorized by the Italian Ministry of Health. The results of the trials were very positive in terms of safety and reliability of the procedures. The follow-up period is still short, but preliminary good results are observed in particular in terms of limited toxicity, that on the whole is less than expected. The paper gives a status report on the experimental phase that completed the CE certification process and then outlines the ongoing activities with also indications on the future trends and the most interesting R&D programmes pursued at CNAO.

  18. Whole body MR imaging: applications in oncology.

    Science.gov (United States)

    Johnston, C; Brennan, S; Ford, S; Eustace, S

    2006-04-01

    This article reviews technique and clinical applications of whole body MR imaging as a diagnostic tool in cancer staging. In particular the article reviews its role as an alternative to scintigraphy (bone scan and PET) in staging skeletal spread of disease, its role in assessing total tumour burden, its role in multiple myeloma and finally its evolving non oncologic role predominantly assessing total body composition.

  19. The Sir Anthony Mamo Oncology Centre

    OpenAIRE

    2015-01-01

    In 2009, the development of a medical brief, effectively detailing the specifications for a purpose-built oncology hospital and including the medical equipment and human resources required, was commenced. Robust engagement by the relevant stakeholders, many of which hailed from the extant Sir Paul Boffa Hospital, ensured a very relevant proposal. The project (ERDF 196), led by the Foundation for Medical Sciences, was subsequently approved for partial funding through Europ...

  20. [Multidisciplinary oncology teams: beware of endless discussions].

    Science.gov (United States)

    Giard, Raimond W M

    2010-01-01

    The continual and increasing complexity of diagnostic and treatment options in oncology demands careful communication, coordination and decision making. Cancer care could be improved by multidisciplinary teamwork. Although this sort of teamwork has many advantages in theory, we know very little about its effectiveness in practice. We have to answer questions such as how teams can accomplish their task most effectively and how we must manage organizations in such a way that team-based working contributes optimally to organizational effectiveness.

  1. Imaging and Data Acquisition in Clinical Trials for Radiation Therapy.

    Science.gov (United States)

    FitzGerald, Thomas J; Bishop-Jodoin, Maryann; Followill, David S; Galvin, James; Knopp, Michael V; Michalski, Jeff M; Rosen, Mark A; Bradley, Jeffrey D; Shankar, Lalitha K; Laurie, Fran; Cicchetti, M Giulia; Moni, Janaki; Coleman, C Norman; Deye, James A; Capala, Jacek; Vikram, Bhadrasain

    2016-02-01

    Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

  2. [The role of emotional labour in oncology].

    Science.gov (United States)

    Szluha, Kornélia; Lazányi, Kornélia; Molnár, Péter

    2007-01-01

    Oncologists and related health care professionals (HCPs) do not only have to follow professional protocols in their everyday work, but also have to communicate proper attitudes towards patients suffering from malignant diseases. This task is often a heavier load than the implementation of professional activities themselves. The present article is based on a survey on HCP work motivation, employment parameters and correlations with emotional labour. Fifty oncology HCPs at Debrecen University Medical Health Sciences Centre volunteered to participate in this survey containing 20 simple-choice questions. More than 90 percent of HCPs make an effort to hide their emotional state, giving way to possible negative side effects. The survey showed significant differences between the level of emotional labour of those working in the field of oncology longer or shorter than ten years. Surface and deep emotional labour is more frequent among professionals already working in oncology for a longer period of time. This can serve us with explanation to the burn-out syndrome so frequent in this profession. To diminish the load of emotional labour, healthcare institutes have to aim at hiring employees that spontaneously fit the emotional and behavioural norms facing them, and do not need officially prescribed behavioural norms for everyday work. Their constant need for respect and appreciation of their values must be kept in mind, because the capability of genuine emotional labour diminishes parallel to the number of years spent in work.

  3. Database management for a gynecologic oncology service.

    Science.gov (United States)

    Benjamin, I; Noumoff, J S; Carlson, J A; Giuntoli, R L; Morgan, M; Mikuta, J J

    1990-09-01

    With the ready availability of powerful desktop computers, the ability to manage large clinical databases has become practical. A computer can enhance the capability of a gynecologic oncology service to catalog, recall, and analyze data about patients, tumors, and therapies. While commercially available database packages can be used for this purpose, we have developed a custom database for tracking the clinical activity of a busy gynecologic oncology service. The system catalogs data about patients, admissions, tumors, and therapeutic modalities and uses this information to generate several useful reports. The reports are used for daily patient care, fellow and resident case statistics, and clinical research. What is unique about the system is that it is optimized for ease of use. The development of this tumor registry, its user friendliness, and advantages over a manual recordkeeping system are described. Unlike other tumor registries, our system is utilized on a daily basis for patient care. Therefore, the data being entered have an immediate usefulness in addition to being simultaneously added to the tumor register for retrospective clinical research. One may hypothesize that it would be useful if all gynecologic oncology services used a common computerized tumor registry that could allow for the sharing of information on a national or global scale.

  4. Lymphoscintigraphy in oncology: a rediscovered challenge

    Energy Technology Data Exchange (ETDEWEB)

    Valdes Olmos, R.A.; Hoefnagel, C.A. [Netherlands Cancer Inst., Amsterdam (Netherlands). Dept. of Nuclear Medicine; Nieweg, O.E.; Jansen, L.; Rutgers, E.J.T.; Kroon, B.B.R. [Netherlands Cancer Inst., Amsterdam (Netherlands). Dept. of Surgery; Borger, J. [Netherlands Cancer Inst., Amsterdam (Netherlands). Dept. of Radiotherapy; Horenblas, S. [Netherlands Cancer Inst., Amsterdam (Netherlands). Dept. of Urology

    1999-04-01

    The validation of the sentinel node concept in oncology has led to the rediscovery of lymphoscintigraphy. By combining preoperative lymphatic mapping with intraoperative probe detection this nuclear medicine procedure is being increasingly used to identify and detect the sentinel node in melanoma, breast cancer, and in other malignancies such as penile cancer and vulvar cancer. In the past lymphoscintigraphy has been widely applied for various indications in oncology, and in the case of the internal mammary lymph-node chain its current use in breast cancer remains essential to adjust irradiation treatment to the individual findings of each patient. In another diagnostic area, lymphoscintigraphy is also useful to document altered drainage patterns after surgery and/or radiotherapy; its use in breast cancer patients with upper limb oedema after axillary lymph-node dissection or in melanoma patients with lower-extremity oedema after groin dissection can provide information for physiotherapy or reconstructive surgery. Finally, the renewed interest in lymphoscintigraphy in oncology has led not only to the rediscovery of findings from old literature reports, but also to a discussion about methodological aspects such as tracer characteristics, image acquisition or administration routes, as well as to discussion on the study of migration patterns of radiolabelled colloid particles in the context of cancer dissemination. All this makes the need for standardized guidelines for lymphoscintigraphy mandatory. (orig.) With 10 figs., 1 tab., 56 refs.

  5. National University Consortium on Microwave Research (NUCOMR)

    Science.gov (United States)

    Barker, Robert J.; Agee, Forrest J.

    1995-09-01

    This paper introduces a new cooperative research program of national scale that is focused on crucial research issues in the development of high energy microwave sources. These have many applications in the DOD and industry. The Air Force Office of Scientific Research (AFOSR), in coopertaion with the Phillips Laboratory, the Naval Research Laboratory, and the Army Research Laboratory, has established a tri-service research consortium to investigate novel high energy microwave sources. The program is part of the DODs 'Multidisciplinary University Research Initiative' and will be funded at a rate of $DLR3.0M per year for up to five years. All research performed under this program will be unclassified. Under its auspices, HPM scientists at nine US universities will be attacking twenty-two separate research projects under the leadership of Neville Luhmann at UC-Davis, Victor Granatstein at Maryland, Magne Kristiansen at Texas Tech, Edl Schamiloglu at New Mexico, John Nation at Cornell, Ned Birdsall at UC-Berkeley, George Caryotakis at Standord, Ronald Gilgenbach at Michigan, and Anthony Lin at UCLA. To facilitate the rapid transition of research results into the industrial community, formal collaborative subcontracts are already in place with James Benford at Physics International, Carter Armstrong at Northrop, and Glen Huffman at Varian Associates. Although this new program officially only came into existence in mid-March of this year, it builds on over a decade of microwave research efforts funded by the plasma physics office at AFOSR. It also is synergistic with the ongoing Tri-Service Vacuum Electronics Initiative led by Robert Parker of NRL as well as with the AFOSR's and Rome Laboratory's long standing Advanced Thermionic Research Initiative. An overview will be given of the broad spectrum of research objectives encompassed by NUCOMR. Areas of collaboration and technology transfer will be highlighted. The areas in which the three university consortia will conduct

  6. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences.

    NARCIS (Netherlands)

    Vries, M.C. de; Houtlosser, M.; Wit, J.M.; Engberts, D.P.; Bresters, D.; Kaspers, G.J.L.; Leeuwen, E. van

    2011-01-01

    BACKGROUND: Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences o

  7. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences.

    NARCIS (Netherlands)

    Vries, M.C. de; Houtlosser, M.; Wit, J.M.; Engberts, D.P.; Bresters, D.; Kaspers, G.J.L.; Leeuwen, E. van

    2011-01-01

    BACKGROUND: Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences

  8. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences.

    NARCIS (Netherlands)

    Vries, M.C. de; Houtlosser, M.; Wit, J.M.; Engberts, D.P.; Bresters, D.; Kaspers, G.J.L.; Leeuwen, E. van

    2011-01-01

    BACKGROUND: Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences o

  9. Evaluation of the effect on cardiac repolarization (QTc interval) of oncologic drugs.

    Science.gov (United States)

    Morganroth, J

    2007-01-01

    The 12-lead electrocardiograph (ECG) is the standard safety measurement used in clinical trials to identify drug-induced cardiac adverse effects. Drug-induced prolongation of the QTc interval (the measure of cardiac repolarization change), when excessive and in conjunction with the right risk factors, can degenerate into a polymorphic ventricular tachycardia called torsades de pointes and has become a new focus for new drug development. The assessment of an ECG in clinical practice using machine-defined QTc duration is intrinsically unreliable. Current regulatory concepts have focused on the need for measuring ECG intervals using manual techniques using digital processing in a central ECG laboratory. The QT interval is subject to a large degree of spontaneous variability requiring attention to basic clinical trial design issues such as sample size (use as large a cohort as possible), frequency of measurements taken (at least three to six ECGs at baseline and at many time points on therapy with pharmacokinetic samples if possible), and their accuracy. Since most oncologic products are cytotoxic, a Thorough or Dedicated ECG Trial cannot be conducted and in the usual trail, especially in phase I, all changes seen on the ECG will be attributed to the new oncology drug. For most nononcologic drugs, there is regulatory guidance on how much an effect on QTc duration might be related to the risk of cardiac toxicity. For oncology products, the central tendency magnitude and proportion of outliers needs to be well defined to construct a label if the risk-benefit analysis leads to marketing approval. Clinical cardiac findings such as syncope, ventricular tachyarrhythmias, and other cardiac effects will be important in this analysis.

  10. Advances in industrial microbiome based on microbial consortium for biorefinery.

    Science.gov (United States)

    Jiang, Li-Li; Zhou, Jin-Jie; Quan, Chun-Shan; Xiu, Zhi-Long

    2017-01-01

    One of the important targets of industrial biotechnology is using cheap biomass resources. The traditional strategy is microbial fermentations with single strain. However, cheap biomass normally contains so complex compositions and impurities that it is very difficult for single microorganism to utilize availably. In order to completely utilize the substrates and produce multiple products in one process, industrial microbiome based on microbial consortium draws more and more attention. In this review, we first briefly described some examples of existing industrial bioprocesses involving microbial consortia. Comparison of 1,3-propanediol production by mixed and pure cultures were then introduced, and interaction relationships between cells in microbial consortium were summarized. Finally, the outlook on how to design and apply microbial consortium in the future was also proposed.

  11. Evaluation of production of lettuce and radish in consortium

    Directory of Open Access Journals (Sweden)

    Adriano Santos Valete Damasceno

    2016-08-01

    Full Text Available The aim of this study was to evaluate the viability of radish-lettuce consortium, as well as the best arrangement for the development of the vegetables. The experiment was carried out in randomized block design, in the University of Mato Grosso – UNEMAT, Campus Alta Floresta. It were evaluated the cropping system of lettuce, radish, and the consortium between cultures in two arrangements (three rows of lettuce with two rows of radish and three rows of radish with two rows of lettuce, with 6 replications. Evaluated characteristics were total fresh weight, commercial fresh weight, leaf fresh weight and number of leaves by plants. Means were compared by Scott-Knott test, at 5% of probability. The arrangement with three lettuce crop rows and two radish proved feasible, with promising for use in the consortium system.

  12. The ISPRS Student Consortium: From launch to tenth anniversary

    Science.gov (United States)

    Kanjir, U.; Detchev, I.; Reyes, S. R.; Akkartal Aktas, A.; Lo, C. Y.; Miyazaki, H.

    2014-04-01

    The ISPRS Student Consortium is an international organization for students and young professionals in the fields of photogrammetry, remote sensing, and the geospatial information sciences. Since its start ten years ago, the number of members of the Student Consortium has been steadily growing, now reaching close to 1000. Its increased popularity, especially in recent years, is mainly due to the organization's worldwide involvement in student matters. The Student Consortium has helped organize numerous summer schools, youth forums, and student technical sessions at ISPRS sponsored conferences. In addition, the organization publishes a newsletter, and hosts several social media outlets in order to keep its global membership up-to-date on a regular basis. This paper will describe the structure of the organization, and it will give some example of its past student related activities.

  13. A Review of Shared Decision-Making and Patient Decision Aids in Radiation Oncology.

    Science.gov (United States)

    Woodhouse, Kristina Demas; Tremont, Katie; Vachani, Anil; Schapira, Marilyn M; Vapiwala, Neha; Simone, Charles B; Berman, Abigail T

    2017-01-30

    Cancer treatment decisions are complex and may be challenging for patients, as multiple treatment options can often be reasonably considered. As a result, decisional support tools have been developed to assist patients in the decision-making process. A commonly used intervention to facilitate shared decision-making is a decision aid, which provides evidence-based outcomes information and guides patients towards choosing the treatment option that best aligns with their preferences and values. To ensure high quality, systematic frameworks and standards have been proposed for the development of an optimal aid for decision making. Studies have examined the impact of these tools on facilitating treatment decisions and improving decision-related outcomes. In radiation oncology, randomized controlled trials have demonstrated that decision aids have the potential to improve patient outcomes, including increased knowledge about treatment options and decreased decisional conflict with decision-making. This article provides an overview of the shared-decision making process and summarizes the development, validation, and implementation of decision aids as patient educational tools in radiation oncology. Finally, this article reviews the findings from decision aid studies in radiation oncology and offers various strategies to effectively implement shared decision-making into clinical practice.

  14. The Oncopig Cancer Model: An Innovative Large Animal Translational Oncology Platform

    DEFF Research Database (Denmark)

    Schachtschneider, Kyle M.; Schwind, Regina M.; Newson, Jordan

    2017-01-01

    in bridging the gap between fundamental diagnostic and therapeutic discoveries and human clinical trials. Such animal models offer insights into all aspects of the basic science-clinical translational cancer research continuum (screening, detection, oncogenesis, tumor biology, immunogenicity, therapeutics......-the Oncopig Cancer Model (OCM)-as a next-generation large animal platform for the study of hematologic and solid tumor oncology. With mutations in key tumor suppressor and oncogenes, TP53R167H and KRASG12D , the OCM recapitulates transcriptional hallmarks of human disease while also exhibiting clinically...

  15. Past and present achievements, and future direction of the Gastrointestinal Oncology Study Group (GIOSG), a Division of Japan Clinical Oncology Group (JCOG).

    Science.gov (United States)

    Boku, Narikazu

    2011-12-01

    Initially, Gastrointestinal Study Group in Japan Clinical Oncology Group (GIOSG/JCOG) focused on gastric cancer. In 1980s, fluoropyrimidine, cisplatin and mitomycin C were key drugs. A randomized Phase II trial (JCOG8501) comparing futrafur plus mitomycin C and uracil plus futrafur and mitomycin C showed a higher response rate of uracil plus futrafur and mitomycin C than futrafur plus mitomycin C. From the results of two Phase II trials of etoposide, adriamycin and cisplatin, and cisplatin plus 5-fluorouracil, uracil plus futrafur and mitomycin C and cisplatin plus 5-fluorouracil were adopted for the test arms of the Phase III trial (JCOG9205) comparing with continuous infusion of 5-fluorouracil as a control arm. Neither cisplatin plus 5-fluorouracil nor uracil plus futrafur and mitomycin C showed a survival benefit over continuous infusion of 5-fluorouracil. In late 1990s, new agents, irinotecan and S-1, were developed for gastric cancer in Japan. GIOSG conducted a Phase III trial (JCOG9912) investigating superiority of irinotecan plus cisplatin and non-inferiority of monotherapy with S-1 compared with continuous infusion of 5-fluorouracil, and S-1 succeeded in showing non-inferiority. Then, SPIRITS trial showed a survival benefit of S-1 plus cisplatin over S-1, resulting in the establishment of a standard care for advanced gastric cancer in Japan. GIOSG have merged with Gastric Cancer Study Group as the Stomach Cancer Study Group (SCSG) from 2011. Recent progress in the development of new drugs has been remarkable. From the point of the roles shared with many other study groups for clinical trials, including registration trials of new drugs conducted by pharmaceutical companies, SCSG should recognize its role and conduct clinical trials with high quality for establishing new standard treatment.

  16. Midwest Superconductivity Consortium - Final Progress Report October 2001

    Energy Technology Data Exchange (ETDEWEB)

    Bement, Arden L.

    2001-10-23

    The basic mission of the Consortium was to advance the science and understanding of high-T{sub c} superconductivity and to promote the development of new materials and improved processing technology. Focused group efforts were the key element of the research program. One program area is the understanding of the layered structures involved in candidate materials and the factors that control their formation, stability and relationship superconductor properties. The other program area had a focus upon factors that limit or control the transport properties such as weak links, flux lattice behavior, and interfaces. Interactions among Consortium d with industrial armiates were an integral part of the program.

  17. Augmentation of a Microbial Consortium for Enhanced Polylactide (PLA) Degradation.

    Science.gov (United States)

    Nair, Nimisha R; Sekhar, Vini C; Nampoothiri, K Madhavan

    2016-03-01

    Bioplastics are eco-friendly and derived from renewable biomass sources. Innovation in recycling methods will tackle some of the critical issues facing the acceptance of bioplastics. Polylactic acid (PLA) is the commonly used and well-studied bioplastic that is presumed to be biodegradable. Considering their demand and use in near future, exploration for microbes capable of bioplastic degradation has high potential. Four PLA degrading strains were isolated and identified as Penicillium chrysogenum, Cladosporium sphaerospermum, Serratia marcescens and Rhodotorula mucilaginosa. A consortium of above strains degraded 44 % (w/w) PLA in 30 days time in laboratory conditions. Subsequently, the microbial consortium employed effectively for PLA composting.

  18. An increase in medical student knowledge of radiation oncology: a pre-post examination analysis of the oncology education initiative.

    Science.gov (United States)

    Hirsch, Ariel E; Mulleady Bishop, Pauline; Dad, Luqman; Singh, Deeptej; Slanetz, Priscilla J

    2009-03-15

    The Oncology Education Initiative was created to advance oncology and radiation oncology education by integrating structured didactics into the existing core radiology clerkship. We set out to determine whether the addition of structured didactics could lead to a significant increase in overall medical student knowledge about radiation oncology. We conducted a pre- and posttest examining concepts in general radiation oncology, breast cancer, and prostate cancer. The 15-question, multiple-choice exam was administered before and after a 1.5-hour didactic lecture by an attending physician in radiation oncology. Individual question changes, overall student changes, and overall categorical changes were analyzed. All hypothesis tests were two-tailed (significance level 0.05). Of the 153 fourth-year students, 137 (90%) took the pre- and posttest and were present for the didactic lecture. The average test grade improved from 59% to 70% (p = 0.011). Improvement was seen in all questions except clinical vignettes involving correct identification of TNM staging. Statistically significant improvement (p cancer, delivery of radiation treatment, and management of early-stage breast cancer. Addition of didactics in radiation oncology significantly improves medical students' knowledge of the topic. Despite perceived difficulty in teaching radiation oncology and the assumption that it is beyond the scope of reasonable knowledge for medical students, we have shown that even with one dedicated lecture, students can learn and absorb general principles regarding radiation oncology.

  19. New generation of breast cancer clinical trials implementing molecular profiling

    Institute of Scientific and Technical Information of China (English)

    Dimitrios Zardavas; Martine Piccart-Gebhart

    2016-01-01

    The implementation of molecular profiling technologies in oncology deepens our knowledge for the molecular landscapes of cancer diagnoses, identifying aberrations that could be linked with specific therapeutic vulnerabilities. In particular, there is an increasing list of molecularly targeted anticancer agents undergoing clinical development that aim to block specific molecular aberrations. This leads to a paradigm shift, with an increasing list of specific aberrations dictating the treatment of patients with cancer. This paradigm shift impacts the field of clinical trials, since the classical approach of having clinico-pathological disease characteristics dictating the patients' enrolment in oncology trials shifts towards the implementation of molecular profiling as pre-screening step. In order to facilitate the successful clinical development of these new anticancer drugs within specific molecular niches of cancer diagnoses, there have been developed new, innovative trial designs that could be classified as follows: i) longitudinal cohort studies that implement (or not) "nested" downstream trials, 2) studies that assess the clinical utility of molecular profiling, 3) "master" protocol trials, iv) "basket" trials, v) trials following an adaptive design. In the present article, we review these innovative study designs, providing representative examples from each category and we discuss the challenges that still need to be addressed in this era of new generation oncology trials implementing molecular profiling. Emphasis is put on the field of breast cancer clinical trials.

  20. Randomized Trial of Interleukin-2 IL-2) as Early Consolidation Following Marrow Ablative Therapy with Stem Cell Rescue for Metastatic Breast Cancer

    Science.gov (United States)

    2005-10-01

    DeVita VT, Jr., Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology (ed 6th). Philadelphia, Lippincott, Williams and Wilkins...shortly after this proposal was funded in 1999, a series of randomized trials was reported at the American Society of Clinical Oncology meetings in 5/00...8217~. Two breast cancer medical oncology specialists (Dr. John H. Ward and Dr. Saundra Buys), from the Huntsman Cancer Institute were added as co

  1. [Donatori di Musica: when oncology meets music].

    Science.gov (United States)

    Graiff, Claudio

    2014-10-01

    Donatori di Musica is a network of musicians - both physicians and volunteers - that was initially founded in 2009 with the aim to set up and coordinate classical music concerts in hospitals. This activity was initially started and led by the Oncology Departments at Carrara and Bolzano Hospitals, where high profile professional musicians make themselves available for concerts in support of Oncological in/out-patients of that specific Hospital. A live classical music performance is a deeply touching experience - particularly for those who live a critical condition like cancer. Main characteristics of Donatori di Musica concerts are: continuity (concerts are part of a regular and non-stopping music season); quality (concerts are held by well-established professional musicians); philanthropic attitude (musicians do not wear a suit and usually chat with patients; they also select an easy-to-listen program; a convivial event is usually organized after the performance with the aim of overcoming distinctions and barriers between physician and patient); no profit: musicians perform for free - travel expenses and/or overnight staying only can be claimed; concerts have free access for patients, their families and hospital staff.Patients and musicians therefore do get in close contact and music is able to merge each other experiences - with patients being treated by the beauty of music and musicians being treated theirselves by patients daily-life feedback. The Donatori di Musica experience is therefore able to help Medicine to retrieve its very first significance - the medical act regain that human and cultural dimension that seems to be abandoned in the last decades in favour of a mere technicism. This is the spirit and the deep significance of Donatori di Musica - «[…] the hope that Music can become a key support to medical treatments in every Oncology department» (by Gian Andrea Lodovici).