Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Epoetin Alfa; Fluorouracil; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas

• No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms

• Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons

• Primary cancer in the head, body, or tail of pancreas

• Measurable disease

• No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis

• No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count greater than 2,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor)

• Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy

Renal

• Creatinine less than 1.7 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Other

• No other malignancy within the past 3 years except nonmelanoma skin cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for this disease

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to pancreas

Surgery

• Not specified