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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