Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.

Interventions: Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox).
Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site.
Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks.
Primary outcome(s): Disease free survival, determined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause.[During treatment: prior to each treatment cycle. Patients on the 3 month treatment arm will be reviewed 4 weekly for the first twelve weeks after completion of chemotherapy. Clinical examination and Carcinoembryonic Antigen test will be performed at each visit. Follow-up: assessment will be at three monthly intervals until month 12 then 6 monthly until month 24 and annually thereafter.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy