TROG 99.02 Concurent radiation and chemotherapy for the organ conserving treatment of early anal canal cancer

Interventions: concurrent radiation and chemotherapy over a total of 7 weeks 3 days.
Radiation:50.4 Gy given in split course - initial phase 36 Gy in 18 fractions to primary +/- perirectal nodes followed after 2 week gap with 14.4 Gy in 8 fractions to primary alone.
Chemotherapy: 5FU 800mg/m2/day (maximum 1.5gm a day) given by intravenous infusion (IV) Days 1-4 and Days 43-46 and Mitomycin C 10mg/m2 (maximum 15mg) by intravenous (IV) bolus Day 1 only.
Primary outcome(s): To test the hypothesis that this chemoradiation schedule can acheive a 5 year colostomy free survival in 85% of patients with less than 10% Grade 3 and 4 Radiation Therapy Oncology Group (RTOG) late toxicity.
Colostomy free survival is assessed by clinical assessment. Late toxicity is scored using the Radiation Therapy Oncology Group /European Organisation for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Scheme[Follow up schedule for clinical assessment is 1,2,3, 6 months after completion of treatment and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5.
Late toxicity is scored by physician scored toxicity forms at 6 months post completion of treatment and and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial