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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Cancer

Treatments: Radiation: radiation therapy; Drug: fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT00010062

CDR0000068438

EU-20022

FRE-GERCOR-D98-1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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