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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00030511
• Other study ID #: EORTC-05991
• Secondary ID: EORTC-05991
• Status: Terminated
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: July 13, 2012
• Start date: October 2001

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Bile Duct Cancer
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• fluorouracil

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Hopital de Jolimont	Haine Saint Paul
Belgium	Les Cliniques Saint-Joseph ASBL	Liege
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Hopital Cochin	Paris
France	Hopital Paul Brousse	Villejuif
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

United States,  Belgium,  France,