Chemotherapy or No Chemotherapy in Clear Margins After Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer. A Randomised Phase III Trial of Control Vs Capecitabine Plus Oxaliplatin [CHRONICLE]
- Compare the efficacy of adjuvant chemotherapy comprising capecitabine and oxaliplatin
vs standard follow-up care, in terms of disease-free and overall survival, in patients
with clear margins after complete resection of locally advanced rectal cancer.
OUTLINE: This is an open-label, randomized, controlled, prospective, multicenter study.
Patients are stratified according to surgeon and nodal status (node positive vs node
negative vs unknown). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard follow up.
- Arm II: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV
over 2 hours on day 1. Treatment repeats every 3 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 5 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 3 years
Robert Glynne-Jones, MD
Mount Vernon Cancer Centre at Mount Vernon Hospital