Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborators: National Cancer Institute (NCI); Radiation Therapy Oncology Group
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Locally advanced or regional (encompassable within the same radiotherapy portals)

• Adenosquamous cancers are allowed

• Unresectable disease

• Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.

• Age>=18

• ECOG Performance status of 0-1

• Life expectancy >= 12 weeks

• Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:

• Absolute granulocyte count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)

• Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)

• Albumin greater than 2.5 g/dL

• Creatinine no greater than 1.5 times ULN

• Fertile patients must use effective contraception

• Willing and able to attend follow-up visits

• Concurrent enrollment on protocol ECOG-E1Y03 allowed

• More than 4 weeks since prior investigational agents

Exclusion Criteria:

• Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)

• Stage M1 disease

• Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology

• Pregnant or nursing

• Active infection within within 4 weeks of randomization

• Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)

• History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)

• Signs or symptoms of peptic or duodenal ulcer disease

• Concurrent serious systemic disorders that are incompatible with study participation

• Prior chemotherapy for pancreatic cancer

• Prior radiotherapy

• Concurrent intensity modulated radiotherapy