This application is a request for continued support (in part) for the EORTC Data Center. The purpose of the grant is to assist the EORTC Data Center in providing statistical assistance and expertise to the clinical cooperative groups of the EORTC. This includes advice on the design of multicenter clinical trials, writing of protocols, design of forms, development of data handling and processing, quality assurance both at the Data Center and in situ, central randomization, and use of advanced statistical and computer techniques. Trial data are made available to NCI whenever requested (196 multicenter trials in progress). The EORTC Data Center has its own research program in applied statistics and methodology of clinical trials. To facilitate communication, the EORTC Data Center has developed a private electronic network (EuroCODE) which permits on-line randomization, electronic mail, access to a number of dedicated databases, and the use of PDQ.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Cancer Clinical Investigation Review Committee (CCI)
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European Org/Research/Treatment/Cancer
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Seymour, Lesley; Bogaerts, Jan; Perrone, Andrea et al. (2017) iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol 18:e143-e152
Ediebah, Divine E; Reijneveld, Jaap C; Taphoorn, Martin J B et al. (2017) Impact of neurocognitive deficits on patient-proxy agreement regarding health-related quality of life in low-grade glioma patients. Qual Life Res 26:869-880
Schwartz, Lawrence H; Litière, Saskia; de Vries, Elisabeth et al. (2016) RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer 62:132-7
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
Schwartz, Lawrence H; Seymour, Lesley; Litière, Saskia et al. (2016) RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group. Eur J Cancer 62:138-45
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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
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; 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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