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

Phase 2
Conditions
Pancreatic Cancer
Registration Number
NCT00010062
Lead Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (29)

Hopital Claude Gallien

🇫🇷

Quincy Sous Senart, France

Hopital Laennec

🇫🇷

Paris, France

Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie

🇫🇷

Gien, France

Clinique Saint Vincent

🇫🇷

Saint Gregoire, France

Hopital Beaujon

🇫🇷

Clichy, France

CHR de Grenoble - La Tronche

🇫🇷

Grenoble, France

Clinique Ste - Marie

🇫🇷

Pontoise, France

Clinique De Savoie

🇫🇷

Annemasse, France

Centre Regional Francois Baclesse

🇫🇷

Caen, France

Clinique Tivoli

🇫🇷

Bordeaux, France

Clinique Saint - Jean

🇫🇷

Cagne-sur-Mer, France

Clinique Floreal

🇫🇷

Bagnolet, France

Hopital Fontenoy

🇫🇷

Chartres, France

Polyclinique Saint Jean

🇫🇷

Cagnes Sur Mer, France

Hopital Louis Mourier

🇫🇷

Colombes, France

Hopital Drevon

🇫🇷

Dijon, France

Clinique Pasteur

🇫🇷

Toulouse, France

Hopital Tenon

🇫🇷

Paris, France

Centre Jean Bernard

🇫🇷

Le Mans, France

Clinique Claude Bernard

🇫🇷

Ermont, France

Hopital Saint - Louis

🇫🇷

La Rochelle, France

Centre Hospital Regional Universitaire de Limoges

🇫🇷

Limoges, France

Hopital Saint Antoine

🇫🇷

Paris, France

CHU Pitie-Salpetriere

🇫🇷

Paris, France

Centre du Rouget

🇫🇷

Sarcelles, France

Polyclinique De Courlancy

🇫🇷

Reims, France

C.H. Senlis

🇫🇷

Senlis, France

Centre Medico-Chirurgical Foch

🇫🇷

Suresnes, France

Hopital de la Ville D'Esch-sur-Alzette

🇱🇺

Esch-sur-Alzette, Luxembourg

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