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Intervention protocol 05

ChemoRadiotherapy after induction chemotherapy in cancer of the stomach (CRITICS)

Objectives Worldwide gastric cancer is the second most diagnosed malignancy. This international multicenter study investigates whether chemoradiotherapy (RT with weekly cisplatin and daily capecitabine) after preoperative chemotherapy leads to improved survival in comparison with postoperative chemotherapy.
Study outline (intervention) Patients will be randomized to either chemo-surgery-chemoRT (45Gy/5weeks with weekly cisplatin and daily capecitabine) or chemo-surgery-chemo (3xECC). The pre-op chemo is 3xECC (epirubicin, cisplatin, capecitabine). Morbidity will be scored using NCI Common Toxicity Criteria (CTC version 3.0) as well as health related quality of life (HRQL). Furthermore, translational research on genomic and proteomic profiling including studies on Ebstein Bar Virus (EBV) associated gastric cancer will be studied in response to therapy. The study is expected to be activated in Denmark from autumn 2008 and to accrue a minimum of 75 patients per year. In total the international group expects 788 patients. A 10% absolute improvement in overall and disease specific survival is expected with manageable toxicity.
Expected impact Chemoradiotherapy is expected to improve loco-regional control and survival for gastric cancer patients. Importantly, this trial opens for DK to participate in international frontline research in gastric cancer improving the quality of treatment as well as advancing individualized radiotherapy and patient selection to a potentially curable yet toxic treatment.
Linkages with work packages WP 1, 2, 6, 7. The protocol adds translational research on genomic and proteomic profiling (WP01) to explore prediction of response and recurrence risk in gastric cancer. Tools from biological imaging (WP02), new markers for IGRT (WP07) and adaptive IG-IMRT (WP06) will be used.