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CAO/ARO/AIO-04

(similar design PETACC-6)

Inclusion criteria: cT3-4 or N+

R

RT 50.4 Gy

(@1.8Gy)

+

1000 mg/m² days 1-5 + 29-33

T

M

E

5-FU bolus

4 cycles

(4 months)

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

pCR as unplanned exploratory analysis

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

T

M

E

mFOLFOX6

8 cycles

(4 months)