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Home > "F" Clinical Trials Conditions > Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

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



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

For Condition: stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer,stage 2 pancreatic cancer,stage 1 pancreatic cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JacquesBalosso,  Study Chair,  CHR de Grenoble - La Tronche

Hopital Claude Gallien
Quincy-sous-Senart,  ,  91480
France
 

Clinique Ste - Marie
Pontoise,  ,  95301
France
 

Clinique Claude Bernard
Ermont,  ,  95120
France
 

Clinique Saint - Jean
Cagne-sur-Mer,  ,  06800
France
 

Hopital Louis Mourier
Colombes,  , 
France
 

Clinique Saint Vincent
Saint-Gregoire,  ,  35700
France
 

Centre Medico-Chirurgical Foch
Suresnes,  ,  92151
France
 

Centre Regional Francois Baclesse
Caen,  ,  14076
France
 

Hopital Tenon
Paris,  ,  75970
France
 

Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
Gien,  ,  45500
France
 

CHR de Grenoble - La Tronche
Grenoble,  ,  F-38043
France
 

Hopital Beaujon
Clichy,  ,  92118
France
 

CHU Pitie-Salpetriere
Paris,  ,  75651
France
 

Hopital Fontenoy
Chartres,  ,  28018
France
 

Polyclinique Saint Jean
Cagnes-sur-Mer,  , 
France
 

Hopital Saint - Louis
La Rochelle,  ,  17000
France
 

Clinique De Savoie
Annemasse,  ,  74100
France
 

Centre Hospital Regional Universitaire de Limoges
Limoges,  ,  87042
France
 

Clinique Floreal
Bagnolet,  ,  28630
France
 

Hopital Saint Antoine
Paris,  ,  75571
France
 

Centre Jean Bernard
Le Mans,  ,  72000
France
 

Clinique Pasteur
Toulouse,  ,  31076
France
 

Polyclinique De Courlancy
Reims,  ,  F-51100
France
 

Clinique Pasteur
Evreux,  ,  27000
France
 

Centre du Rouget
Sarcelles,  ,  95250
France
 

Clinique Tivoli
Bordeaux,  ,  F-33030
France
 

Hopital Laennec
Paris,  ,  75007
France
 

C.H. Senlis
Senlis,  ,  60309
France
 

Hopital Drevon
Dijon,  ,  21000
France
 

Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette,  ,  L-4005
Luxembourg
 


Additional Information:
Study ID Numbers:
  CDR0000068438;  EU-20022,FRE-GERCOR-D98-1
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010062

Other Stage 4a Pancreatic Cancer Studies:
1. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

2. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas

3. Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine

4. Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer

5. Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed

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