Liver Cancer Clinical Trial
Official title:
A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Giving capecitabine after surgery may kill any tumor cells that remain after surgery.
Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this
case, observation may be sufficient. It is not yet known whether capecitabine is more
effective than observation in treating biliary tract cancer.
PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works
compared with observation in treating patients with biliary tract cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
toxicity.
- 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
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