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	Treatment or Intervention	Phase
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IVA pancreatic cancer	Drug: fluorouracil  Procedure: chemotherapy  Procedure: radiation therapy	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Jacques Balosso, MD, PhD,  Study Chair,  CHR de Grenoble - La Tronche   

Study ID Numbers:  CDR0000068438; FRE-GERCOR-D98-1; EU-20022
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010062
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08