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STAR-01

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

R

RT 50.4 Gy

(@1.8Gy)

+

5-FU c.i. 225 mg/m

2

/d

T

M

E

Adjuvant

treatment

5-FU based

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

pCR as protocol-planned comparative analysis

RT 50.4 Gy

(@1.8Gy)

+

5-FU c.i. 225 mg/m

2

/d

Oxaliplatin 60 mg/m

2

weekly

T

M

E

Adjuvant

treatment

5-FU based