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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10CA011488-41
Application #
8019851
Study Section
Subcommittee G - Education (NCI)
Program Officer
Mooney, Margaret M
Project Start
1981-12-01
Project End
2015-11-30
Budget Start
2011-04-01
Budget End
2011-11-30
Support Year
41
Fiscal Year
2011
Total Cost
$232,518
Indirect Cost
Name
European Org/Research/Treatment/Cancer
Department
Type
DUNS #
763839466
City
Brussels
State
Country
Belgium
Zip Code
1200
Baumert, Brigitta G; Hegi, Monika E; van den Bent, Martin J et al. (2016) Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol 17:1521-1532
Fei, F; Messina, C; Slaets, L et al. (2015) Tumour size is the only predictive factor of distant recurrence after pathological complete response to neoadjuvant chemotherapy in patients with large operable or locally advanced breast cancers: a sub-study of EORTC 10994/BIG 1-00 phase III trial. Eur J Cancer 51:301-9
Bonnefoi, H; Jacot, W; Saghatchian, M et al. (2015) Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline-based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study. Ann Oncol 26:325-32
Ediebah, Divine E; Galindo-Garre, Francisca; Uitdehaag, Bernard M J et al. (2015) Joint modeling of longitudinal health-related quality of life data and survival. Qual Life Res 24:795-804
Oosterveld, Margriet; Suciu, Stefan; Muus, Petra et al. (2015) Specific scoring systems to predict survival of patients with high-risk myelodysplastic syndrome (MDS) and de novo acute myeloid leukemia (AML) after intensive antileukemic treatment based on results of the EORTC-GIMEMA AML-10 and intergroup CRIANT studie Ann Hematol 94:23-34
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
Donker, Mila; van Tienhoven, Geertjan; Straver, Marieke E et al. (2014) Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol 15:1303-10
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
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

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