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

Completed · Phase 3

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00057876

Run by

Eastern Cooperative Oncology Group

People needed

74

Starts

2003-08-29

Expected to finish

2009-05-01

Last updated by the study team

2023-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saint Joseph's Mercy Cancer Center — Hot Springs, Arkansas, United States
• California Cancer Center - Woodward Park Office — Fresno, California, United States
• Doctors Medical Center — Modesto, California, United States
• Memorial Medical Center Cancer Services — Modesto, California, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center — Farmington, Connecticut, United States
• New Britain General Hospital — New Britain, Connecticut, United States
• Yale Comprehensive Cancer Center at Yale University School of Medicine — New Haven, Connecticut, United States
• William W. Backus Hospital — Norwich, Connecticut, United States
• Halifax Medical Center — Daytona Beach, Florida, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Emory University Hospital - Atlanta — Atlanta, Georgia, United States
• Veterans Affairs Medical Center - Atlanta (Decatur) — Decatur, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Cancer Care and Research Pavilion at St. Joseph's/Candler — Savannah, Georgia, United States
• Pearlman Comprehensive Cancer Center at South Georgia Medical Center — Valdosta, Georgia, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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