Status: Closed
Activation Date: 2008MAR19
Closing Date: 2009JUL14
Phase: III
Description: Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced Biliary Cancer.
Eligibility: Patients with histologically/cytologically proven adenocarcinoma of the biliary tree (intra and extra-hepatic biliary ducts or gallbladder) that is either unresectable or metastatic. Patient must have evidence of disease but measurable disease is not required. They may not have received previous chemotherapy for advance or metastatic disease unless used as a radiosensitizer. Must have life expectancy > or = 12 weeks.
Objective: Primary: Overall survival. Secondary: Progression-free survival, response rates (CR and PR), rate of stable disease (SD), rate of disease control (CR, PR and SD), response duration, quality of life, toxicity
Participation: Open to member centres
Lay Description: The purpose of this study is to find out whether it is better to receive a capecitabine in combination with gemcitabine, or better to receive only gemictabine for biliary cancer.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
GASTRO-INTESTINAL | BI1 | 19 | 0 | 1 | 1 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
GASTRO-INTESTINAL | BI1 | 19 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
GASTRO-INTESTINAL | BI1 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |