Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

February 6, 2009 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
  • Determine survival without local relapse in these patients treated with this regimen.
  • Determine overall survival of these patients treated with this regimen.
  • Determine the effectiveness of this adjuvant therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annemasse, France, 74100
        • Clinique De Savoie
      • Bagnolet, France, 28630
        • Clinique Floreal
      • Bordeaux, France, F-33030
        • Clinique Tivoli
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Cagne-sur-Mer, France, 06800
        • Clinique Saint - Jean
      • Cagnes Sur Mer, France
        • Polyclinique Saint Jean
      • Chartres, France, 28018
        • Hopital Fontenoy
      • Clichy, France, 92118
        • Hopital Beaujon
      • Colombes, France
        • Hôpital Louis Mourier
      • Dijon, France, 21000
        • Hopital Drevon
      • Ermont, France, 95120
        • Clinique Claude Bernard
      • Evreux, France, 27000
        • Clinique Pasteur
      • Gien, France, 45500
        • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
      • Grenoble, France, F-38043
        • Chr De Grenoble - La Tronche
      • La Rochelle, France, 17000
        • Hopital Saint - Louis
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Limoges, France, 87042
        • Centre Hospital Regional Universitaire de Limoges
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Paris, France, 75007
        • Hôpital Laënnec
      • Pontoise, France, 95301
        • Clinique Ste - Marie
      • Quincy Sous Senart, France, 91480
        • Hopital Claude Gallien
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Saint Gregoire, France, 35700
        • Clinique Saint Vincent
      • Sarcelles, France, 95250
        • Centre du Rouget
      • Senlis, France, 60309
        • C.H. Senlis
      • Suresnes, France, 92151
        • Centre Médico-Chirurgical Foch
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Luxembourg
      • Esch-sur-Alzette, Luxembourg, L-4005
        • Hopital de la Ville D'Esch-sur-Alzette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic adenocarcinoma
  • Complete macroscopic resection of tumor within past 30 days
  • No residual visceral or peritoneal metastasis
  • Involvement of Vater's ampulla or extrahepatic bile duct allowed
  • No vesicular or intrahepatic cholangiocarcinomas

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Alkaline phosphatase less than 3 times normal
  • Bilirubin less than 1.5 times normal

Renal:

  • Creatinine less than 1.5 times normal

Cardiovascular:

  • No serious cardiac failure

Pulmonary:

  • No serious respiratory failure

Other:

  • No other untreatable malignant tumors
  • No serious psychological, familial, social, or geographical conditions that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for pancreatic adenocarcinoma

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for pancreatic adenocarcinoma
  • No prior radiotherapy in an anatomically proximal region to treatment area

Surgery:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Study Chair: Jacques Balosso, MD, PhD, CHU de Grenoble - Hopital de la Tronche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068438
  • FRE-GERCOR-D98-1
  • EU-20022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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