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

Primary Purpose

Extrahepatic Bile Duct Cancer, Liver Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluorouracil
conventional surgery
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring localized resectable adult primary liver cancer, recurrent adult primary liver cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center at the University of Virginia
  • Hopital de Jolimont
  • Les Cliniques Saint-Joseph ASBL
  • Centre Hospital Regional Universitaire de Limoges
  • Hopital Cochin
  • Hopital Paul Brousse

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
July 13, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00030511
Brief Title
Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer
Official Title
A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
October 2001 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Liver Cancer
Keywords
localized resectable adult primary liver cancer, recurrent adult primary liver cancer, localized extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyvin A. Rich, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Les Cliniques Saint-Joseph ASBL
City
Liege
ZIP/Postal Code
B 4000
Country
Belgium
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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