Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jacques Balosso, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
CHU de Grenoble - Hopital de la Tronche
Authority:
United States: Federal Government
Study ID:
CDR0000068438
NCT ID:
NCT00010062
Start Date:
October 2000
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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