Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
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|ClinicalTrials.gov Identifier: NCT00030511|
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : July 16, 2012
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 or disease||Intervention/treatment||Phase|
|Extrahepatic Bile Duct Cancer Liver Cancer||Drug: fluorouracil Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- Determine the pathologic response rate in patients with primary or recurrent biliary duct carcinoma treated with neoadjuvant radiotherapy and fluorouracil followed by surgical resection.
- Determine the tumor response, morbidity, failure patterns (locoregional vs distant), and survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||July 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030511
|United States, Virginia|
|Cancer Center at the University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Hopital de Jolimont|
|Haine Saint Paul, Belgium, 7100|
|Les Cliniques Saint-Joseph ASBL|
|Liege, Belgium, B 4000|
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Paris, France, 75674|
|Hopital Paul Brousse|
|Villejuif, France, 94804|
|Study Chair:||Tyvin A. Rich, MD||University of Virginia|