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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00789958 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.
Condition | Intervention | Phase |
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Extrahepatic Bile Duct Cancer Gallbladder Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride Procedure: 3-dimensional conformal radiation therapy Procedure: adjuvant therapy Procedure: intensity-modulated radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC) |
Estimated Enrollment: | 80 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to margin of resection (negative [R0] vs microscopically positive [R1]).
After completion of study therapy patients are followed periodically for up to 5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria:
No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including but not limited to any of the following:
PRIOR CONCURRENT THERAPY:
United States, Kansas | |
Tammy Walker Cancer Center at Salina Regional Health Center | Recruiting |
Salina, Kansas, United States, 67401 | |
Contact: William F. Cathcart-Rake, MD 785-452-4860 |
Principal Investigator: | Edgar Ben-Josef, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000619334, SWOG-S0809 |
Study First Received: | November 12, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00789958 |
Health Authority: | Unspecified |
cholangiocarcinoma of the extrahepatic bile duct cholangiocarcinoma of the gallbladder localized extrahepatic bile duct cancer |
localized gallbladder cancer unresectable extrahepatic bile duct cancer unresectable gallbladder cancer |
Bile duct cancer, extrahepatic Gallbladder Diseases Cholangiocarcinoma Capecitabine Biliary Tract Neoplasms Digestive System Neoplasms Gall bladder cancer Carcinoma Digestive System Diseases |
Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Gemcitabine Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |