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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer