Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer
- To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy
lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III
- To conduct an economic analysis of the cost effectiveness of these regimens.
- To compare the randomization methodologies used in this study.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center's recruitment potential. Patients are randomized (within 10 weeks after surgery and
before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment
regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is
determined by the participating center.
- Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described
below)combination chemotherapy (6 additional courses if patient already received 6
courses) for treatment lasting a total of 24 weeks.
- Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no
additional courses if patient already received 6 courses) for treatment lasting a total
of 12 weeks.
The two adjuvant combination chemotherapy regimens are administered as follows:
- OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously
over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of
disease progression or unacceptable toxicity.
- XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine
twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence
of disease progression or unacceptable toxicity.
Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC
QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.
After completion of study treatment, patients are followed periodically for up to 7 years.
Peer Reviewed and Funded by Medical Research Council (MRC)
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3-year disease-free survival
Tim Iveson, FRCP, MD, MRCP, MBBS, BSC
University Hospital Southampton NHS Foundation Trust.
United Kingdom: Medicines and Healthcare Products Regulatory Agency