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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010062
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Radiation: radiation therapy Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
Study Start Date : October 2000

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


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


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


  • Creatinine less than 1.5 times normal


  • No serious cardiac failure


  • No serious respiratory failure


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


Biologic therapy:

  • Not specified


  • No prior chemotherapy for pancreatic adenocarcinoma

Endocrine therapy:

  • Not specified


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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010062

Clinique De Savoie
Annemasse, France, 74100
Clinique Floreal
Bagnolet, France, 28630
Clinique Tivoli
Bordeaux, France, F-33030
Centre Regional Francois Baclesse
Caen, France, 14076
Clinique Saint - Jean
Cagne-sur-Mer, France, 06800
Polyclinique Saint Jean
Cagnes Sur Mer, France
Hopital Fontenoy
Chartres, France, 28018
Hopital Beaujon
Clichy, France, 92118
Hopital Louis Mourier
Colombes, France
Hopital Drevon
Dijon, France, 21000
Clinique Claude Bernard
Ermont, France, 95120
Clinique Pasteur
Evreux, France, 27000
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
Gien, France, 45500
CHR de Grenoble - La Tronche
Grenoble, France, F-38043
Hopital Saint - Louis
La Rochelle, France, 17000
Centre Jean Bernard
Le Mans, France, 72000
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Hopital Laennec
Paris, France, 75007
Hopital Saint Antoine
Paris, France, 75571
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Clinique Ste - Marie
Pontoise, France, 95301
Hopital Claude Gallien
Quincy Sous Senart, France, 91480
Polyclinique De Courlancy
Reims, France, F-51100
Clinique Saint Vincent
Saint Gregoire, France, 35700
Centre du Rouget
Sarcelles, France, 95250
C.H. Senlis
Senlis, France, 60309
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Clinique Pasteur
Toulouse, France, 31076
Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette, Luxembourg, L-4005
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Jacques Balosso, MD, PhD CHU de Grenoble - Hopital de la Tronche Identifier: NCT00010062     History of Changes
Other Study ID Numbers: CDR0000068438
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs