Fig. 3
Outline of the TransValid-KFO179/GRCSG-Trials (TransValid A, TransValid B). TransValid A (validation study): 200 patients will be treated with 5-FU-based (1,000 mg/m2, 120 h continuous i.v. on days 1–5 and 29–33) chemoradiotherapy (radiation, 28 × 1.8 Gy) followed by radical surgery. Adjuvant therapy consists of either four cycles of 5-FU (500 mg/m2, bolus i.v. on days 1–5, repeat on day 29) or, in selected cases based on the clinicians’ discretion, six applications of a shortened FOLFOX regimen (folinic acid 400 mg/m2, 2 h continuous i.v.; oxaliplatin 100 mg/m2, 2 h continuous i.v.; 5-FU 2,400 mg/m2, 46 h continuous i.v.; on days 1, 15, 30, 45, 60, and 75). TransValid B (feasibility study, phase I/II): 50 patients will be treated with chemoradiotherapy (radiation, 28 × 1.8 Gy; 5-FU 250 mg/m2, continuous i.v. on days 1–14 and 22–35; oxaliplatin, 50 mg/m2, 2 h continuous i.v. on days 1, 8, 22, and 29), followed by three applications of a shortened FOLFOX regimen on days 1, 15, and 30 and radical surgery