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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030511 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer.
Condition | Intervention | Phase |
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Extrahepatic Bile Duct Cancer Liver Cancer |
Drug: fluorouracil Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive fluorouracil IV over 12 hours each day radiotherapy is administered. Four to six weeks after completion of chemoradiotherapy, patients undergo surgical resection. Patients with residual disease after resection may undergo boost radiotherapy.
Patients are followed every 12 weeks until disease progression and then every 16 weeks after disease progression.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Virginia | |
Cancer Center at the University of Virginia | |
Charlottesville, Virginia, United States, 22908 | |
Belgium | |
Hopital de Jolimont | |
Haine Saint Paul, Belgium, 7100 | |
Les Cliniques Saint-Joseph ASBL | |
Liege, Belgium, B 4000 | |
France | |
Hopital Paul Brousse | |
Villejuif, France, 94804 | |
Hopital Cochin | |
Paris, France, 75674 | |
Centre Hospital Regional Universitaire de Limoges | |
Limoges, France, 87042 |
Investigator: | Tyvin A. Rich, MD | University of Virginia |
Study ID Numbers: | CDR0000069171, EORTC-05991 |
Study First Received: | February 14, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030511 |
Health Authority: | United States: Federal Government |
localized resectable adult primary liver cancer recurrent adult primary liver cancer localized extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer |
Bile duct cancer, extrahepatic Liver Diseases Digestive System Neoplasms Biliary Tract Neoplasms Liver neoplasms Biliary tract cancer Recurrence |
Liver Neoplasms Digestive System Diseases Bile Duct Diseases Fluorouracil Biliary Tract Diseases Gastrointestinal Neoplasms Bile Duct Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |