A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer
- To determine whether adjuvant chemotherapy with capecitabine has any effect on 2-year
survival compared to expectant treatment alone (observation) in patients who have
undergone a macroscopically complete surgical resection of a biliary tract cancer.
- To compare capecitabine versus observation in terms of 5-year survival, relapse-free
survival, toxicity, quality of life, and health economics.
OUTLINE: This is a multicenter, prospective, randomized study. Patients are stratified
according to surgical center, disease site (hilar/extrahepatic cholangiocarcinoma vs
intrahepatic cholangiocarcinoma vs gallbladder vs intrapancreatic/common bile duct), type of
resection (R0 vs R1), and ECOG performance status (0 vs 1 vs 2). Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive oral capecitabine twice a day on days 1-14. Treatment repeats
every 3 weeks for 8 courses in the absence of disease progression or unacceptable
- Arm II: Patients undergo expectant treatment (observation). Quality of life is assessed
at baseline, every 3 months for 1 year, and then every 6 months for 1 year.
All patients are followed for up to 5 years post-randomization.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Survival at 2 years
Cancer Research Campaign Clinical Trials Centre