TransValid-KFO179/GRCSG-Trial

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The TransValid-KFO179/GRCSG-Trial is a multicenter translational biomarker-driven validation study (validation study, n=200 patients) combined with a highly innovative phase-I/II study (feasibility study, n=50 patients) for treatment of patients with resectable rectal cancer (clinical UICC stages II, III and IV). The trial is directly connected with the DFG–funded Interdisciplinary Clinical Research Unit 179 at Göttingen (KFO179: “Biological basis of individual tumor response in patients with rectal cancer”) and will be performed during the second funding period of the KFO179, starting in March 2011 in close cooperation with qualified centers of the German Rectal Cancer Study Group (GRCSG). The TransValid-KFO179/GRCSG-Trial trial is regarded as a result of the research of the KFO179 during the first funding period (2007-2010). It is expected to contribute significantly to the management of rectal cancer in future multicenter trials of the GRCSG, based on validated sets of biological parameters. These biomarker sets will be based on microarray expression signatures, analysis of single genes of 5-FU metabolism, several parameters of apoptosis and MAP-Kinase pathways and will be derived from thorough research of the KFO179. Beside the validation of biomarkers the TransValid-KFO179/GRCSG-Trial addresses questions of how to integrate biomedical experiments with high-dimensional data into clinical settings on a day-by-day basis. These tasks are demanding and have to date not been accomplished within clinical trials or clinical routine for treatment of rectal cancer patients.