Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
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First Received Date ICMJE | August 10, 2006 | ||||
Last Updated Date | November 2, 2011 | ||||
Start Date ICMJE | March 2006 | ||||
Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Survival at 2 years [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Survival at 2 years | ||||
Change History | Complete list of historical versions of study NCT00363584 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer | ||||
Official Title ICMJE | A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer | ||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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.
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 360 | ||||
Completion Date | |||||
Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00363584 | ||||
Other Study ID Numbers ICMJE | CDR0000492266, CRUK-HE3002, EU-20629, EUDRACT-2005-003318-13, ISRCTN72785446, CRUK-BILCAP, CRUK-BIBF1120 | ||||
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Responsible Party | |||||
Study Sponsor ICMJE | University Hospital Southampton NHS Foundation Trust. | ||||
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Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | October 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |