Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Cholangiocarcinoma

Liver Neoplasms

Metaplasia

Biliary Tract Neoplasms

Gallbladder Neoplasms

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Biliary Tract Cancer

Primary Liver Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Capecitabine

Liver Extracts

Antimetabolites

capecitabine

clinical observation

adjuvant therapy

Clive Stubbs

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.

Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer

A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer

University Hospital Southampton NHS Foundation Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer	NCT00363584	Extrahepatic Bi... Gallbladder Can... Liver Cancer	capecitabine clinical observ... adjuvant therap...	18 Years -	National Cancer Institute (NCI)
Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer	NCT00363584	Extrahepatic Bi... Gallbladder Can... Liver Cancer	capecitabine clinical observ... adjuvant therap...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for anaplastic carcinoma of the gallbladder