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Phase III trials – Investigating

Oxaliplatin

Trial

Eligibility

Fluoropyrimidine

Platform

CAO/ARO/AIO-04 <12cm from anal verge

T3/T4 cN0/N+ TRUS, CT and/or MRI

5FU 1000mg/2 X 5 days

1-5 + 29-33

NSABP R04

N=1606

<12cm; resectable stage II, III TRUS or MRI –

CT if T4/ N1-2

PVI 5FU vs

Capecitabine

FFCD

N=598

Palpable; resectable; T3/4

N0-2; T2 distal anterior

Capecitabine in both

arms

STAR – 01

N=747

Resectable stage II, III (c stage)

<12cm from anal verge

PVI 5FU in both arms

PETTAC 6

N=1090

Stage II or III resectable or expected to

become resectable

<12cm from anal verge

Capecitabine in both

arms