Lower GI 2017

CAO/ARO/AIO-04 (similar design PETACC-6)

Inclusion criteria: cT3-4 or N+

T M E

5-FU bolus 4 cycles (4 months)

RT 50.4 Gy (@1.8Gy) + 1000 mg/m² days 1-5 + 29-33

R

mFOLFOX6 8 cycles (4 months)

T M E

RT 50.4 Gy (@1.8Gy) + 5-FU: 250 mg/m² d 1-14 + 22-35 Oxaliplatin: 50 mg/m² d 1, 8 + 22, 29

Primary endpoint: 3y-DFS (75% to 82%); 1200 pts

pCR as unplanned exploratory analysis