Spots Global Cancer Trial Database for Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

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Trial Identification

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

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

Study ID: NCT00010062

Conditions

Pancreatic Cancer

Interventions

fluorouracil

radiation therapy

Study Description

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.