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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Extrahepatic Bile Duct Cancer, Liver Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed primary or recurrent biliary duct carcinoma from the proximal, middle, or distal bile ducts Measurable or evaluable disease that is considered resectable No distant metastases No non-contiguous liver metastases Resectable extension into adjacent liver allowed No metastasis to peritoneal cavity No Bismuth type 4 lesion or metastasis to celiac axis or para-aortic lymph nodes No tumor encasement of portal vein or hepatic artery No gross ascites PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: No cirrhosis No active cholangitis No fever or signs of infection in biliary drainage system Measurement of C-reactive protein optimal Bilirubin less than 3 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective barrier contraception during and for 3 months after study No weight loss greater than 20% ideal body weight No active duodenal or gastric ulcers No other prior or concurrent primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Procedure: conventional surgery|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized resectable adult primary liver cancer, recurrent adult primary liver cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer