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

Phase 2TerminatedNCT00030511

European Organisation for Research and Treatment of Cancer - EORTC

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Extrahepatic Bile Duct Cancer Liver Cancer

Interventions

fluorouracilDRUG

conventional surgeryPROCEDURE

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Hopital de Jolimont

Haine-Saint-Paul, Belgium

Les Cliniques Saint-Joseph ASBL

Liège, Belgium

Centre Hospital Regional Universitaire de Limoges

Limoges, France

Data from ClinicalTrials.gov

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