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Tracking Information | |||||
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First Received Date † | February 14, 2002 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | October 2001 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00030511 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer | ||||
Official Title † | A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Belgium, France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00030511 | ||||
Responsible Party | |||||
Secondary IDs †† | EORTC-05991 | ||||
Study Sponsor † | European Organization for Research and Treatment of Cancer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | July 2003 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |