Lower GI 2017

STAR-01 Inclusion criteria: cT3-4 or N+, ≤ 75 years

T M E

Adjuvant treatment 5-FU based

RT 50.4 Gy (@1.8Gy) + 5-FU c.i. 225 mg/m 2 /d

R

T M E

RT 50.4 Gy (@1.8Gy) + 5-FU c.i. 225 mg/m 2 /d Oxaliplatin 60 mg/m 2 weekly

Adjuvant treatment 5-FU based

Primary endpoint: OS (30% reduction in mortality rates); 690 pts required.

pCR as protocol-planned comparative analysis