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.
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.
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|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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