The EORTC Headquarters (HQ) is a unique central facility within Europe that offers a comprehensive approach to the management of international, multidisciplinary cancer clinical trials. It provides expertise over a wide range of activities and research areas including data management, statistics, computer science, medical support, regulatory affairs, pharmacovigilance, quality assurance, and quality of life. The goal of this application is to stimulate and facilitate cooperation between the EORTC and US cooperative groups for specific, large scale intergroup trials which will more rapidly bring answers to unmet medical needs. This requires not only coordination of the respective scientific strategies and priorities, but also addresses infrastructure issues to ensure the appropriate conduct of the studies and projects addressed in this application. Besides continuing existing intergroup activities, the EORTC will participate in several new US NCI led randomized phase III studies (brain tumors, pancreatic cancer, cervix cancer) and will take the lead in organizing a prospective intergroup study in male breast cancer. New projects aimed at standardizing procedures to facilitate intergroup cooperation will be undertaken together with our US partners. This includes the development of a platform to facilitate the use of imaging in multicenter intergroup trials, the harmonization of quality assurance programs in radiotherapy (QART), and the further development of RECIST. Additional joint initiatives will also be explored in areas such as clinical trials in the elderly and in rare diseases along with the development of joint trials in lung cancer and collaboration to harmonize biobanking activities for translational research. Through these joint initiatives, new intergroup clinical trials will be undertaken which would be difficult for either organization to carry out by themselves and which should have a major impact on day to day clinical practice on a worldwide basis.

Public Health Relevance

The EORTC's participation in US NCI sponsored studies will benefit the treatment of patients worldwide by increasing the exchange of information between the US and Europe, standardizing clinical trial methodology and treatment policies, allowing more studies in rare tumors to be carried out, and permitting studies to be completed more quickly through increased accrual, thus allowing more studies to be undertaken.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Subcommittee G - Education (NCI)
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Mooney, Margaret M
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European Org/Research/Treatment/Cancer
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Bottomley, Andrew; Tridello, Gloria; Coens, Corneel et al. (2014) An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer 120:390-8
Brausi, Maurizio; Oddens, Jorg; Sylvester, Richard et al. (2014) Side effects of Bacillus Calmette-Guerin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose an Eur Urol 65:69-76
Bonnefoi, H; Litière, S; Piccart, M et al. (2014) Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial. Ann Oncol 25:1128-36
Bosset, Jean-François; Calais, Gilles; Mineur, Laurent et al. (2014) Fluorouracil-based adjuvant chemotherapy after preoperative chemoradiotherapy in rectal cancer: long-term results of the EORTC 22921 randomised study. Lancet Oncol 15:184-90
Ediebah, D E; Coens, C; Zikos, E et al. (2014) Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial. Br J Cancer 110:2427-33
Oddens, Jorg; Brausi, Maurizio; Sylvester, Richard et al. (2013) Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guerin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol 63:462-72
Ediebah, D E; Coens, C; Maringwa, J T et al. (2013) Effect of completion-time windows in the analysis of health-related quality of life outcomes in cancer patients. Ann Oncol 24:231-7
van den Bent, Martin J; Erdem-Eraslan, Lale; Idbaih, Ahmed et al. (2013) MGMT-STP27 methylation status as predictive marker for response to PCV in anaplastic Oligodendrogliomas and Oligoastrocytomas. A report from EORTC study 26951. Clin Cancer Res 19:5513-22
Erdem-Eraslan, Lale; Gravendeel, Lonneke A; de Rooi, Johan et al. (2013) Intrinsic molecular subtypes of glioma are prognostic and predict benefit from adjuvant procarbazine, lomustine, and vincristine chemotherapy in combination with other prognostic factors in anaplastic oligodendroglial brain tumors: a report from EORTC stu J Clin Oncol 31:328-36
Nordlinger, Bernard; Sorbye, Halfdan; Glimelius, Bengt et al. (2013) Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol 14:1208-15

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