NCT00030511

Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer

A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Extrahepatic Bile Duct Cancer
• Liver Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 2001-10-01
• Primary completion: 2003-07-01
• First posted: 2003-01-27
• Last updated: 2012-07-16

Locations

6 sites across 3 countries: United States, Belgium, France