This trial is active, not recruiting.

Condition pancreatic cancer
Treatments fluorouracil, radiation therapy
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date October 2000
Trial identifier NCT00010062, CDR0000068438, EU-20022, FRE-GERCOR-D98-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).