TransValid-KFO179/GRCSG-Trial

TransValid-KFO179/GRCSG试验是一项多中心生物标记物驱动的验证研究(验证研究，n=200名患者)，与高度创新的I/II期研究(可行性研究，n=50名患者)相结合，用于治疗可切除直肠癌患者(临床UICC II、III和IV期)。该试验与德国食品和药物管理局资助的位于哥廷根的跨学科临床研究中心179(KFO179：“直肠癌患者个体肿瘤反应的生物学基础”)直接相关，将于2011年3月开始，与德国直肠癌研究小组(GRCSG)的合格中心密切合作，在KFO179的第二个资助期内进行。TransValid-KFO179/GRCSG-试验被视为在第一个资助期(2007-2010年)对KFO179进行研究的结果。在GRCSG未来的多中心试验中，基于一组经过验证的生物学参数，预计它将对直肠癌的治疗做出重大贡献。这些生物标志物集合将基于微阵列表达特征、5-FU代谢的单基因分析、细胞凋亡的几个参数和MAP-Kinase途径，并将来自对KFO179的深入研究。除了生物标志物的验证外，TransValid-KFO179/GRCSG-Trial还解决了如何将具有高维数据的生物医学实验每天整合到临床环境中的问题。这些任务要求很高，到目前为止还没有在直肠癌患者的临床试验或临床常规治疗中完成。

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.