Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
NCT ID: NCT00010062
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2000-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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fluorouracil
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Jacques Balosso, MD, PhD
Role: STUDY_CHAIR
CHU de Grenoble - Hopital de la Tronche
Locations
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Clinique De Savoie
Annemasse, , France
Clinique Floreal
Bagnolet, , France
Clinique Tivoli
Bordeaux, , France
Centre Regional Francois Baclesse
Caen, , France
Clinique Saint - Jean
Cagne-sur-Mer, , France
Polyclinique Saint Jean
Cagnes-sur-Mer, , France
Hopital Fontenoy
Chartres, , France
Hopital Beaujon
Clichy, , France
Hopital Louis Mourier
Colombes, , France
Hopital Drevon
Dijon, , France
Clinique Claude Bernard
Ermont, , France
Clinique Pasteur
Évreux, , France
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
Gien, , France
CHR de Grenoble - La Tronche
Grenoble, , France
Hopital Saint - Louis
La Rochelle, , France
Centre Jean Bernard
Le Mans, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Hopital Laennec
Paris, , France
Hopital Saint Antoine
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Clinique Ste - Marie
Pontoise, , France
Hopital Claude Gallien
Quincy-sous-Sénart, , France
Polyclinique De Courlancy
Reims, , France
Clinique Saint Vincent
Saint-Grégoire, , France
Centre du Rouget
Sarcelles, , France
C.H. Senlis
Senlis, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
Clinique Pasteur
Toulouse, , France
Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette, , Luxembourg
Countries
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Other Identifiers
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FRE-GERCOR-D98-1
Identifier Type: -
Identifier Source: secondary_id
EU-20022
Identifier Type: -
Identifier Source: secondary_id
CDR0000068438
Identifier Type: -
Identifier Source: org_study_id
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