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

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: * Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy. * Compare the objective response rate in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the quality of life (QOL) of patients treated with these regimens. * Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms. Arm I (Gemcitabine alone): * Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest. * Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Arm II (Gemcitabine with radiotherapy): * Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1. * Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival. ACCRUAL: 74 patients were accrued for this study.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival Time [assessed every 3 months for 2 years, then every 6 months for year 3]. Median, Months (95% Confidence Interval). Gemcitabine (n=37): 9.2 (7.9 to 11.4); Gemcitabine + Radiation (n=34): 11.0 (7.6 to 15.5). Analysis, Gemcitabine vs Gemcitabine + Radiation: p=0.017; Log Rank; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival Time [assessed every 3 months for 2 years, then every 6 months for year 3]. Median, Months (95% Confidence Interval). Gemcitabine (n=34): 6.7 (3.9 to 8.7); Gemcitabine + Radiation (n=33): 6.0 (5.4 to 8.4). Analysis, Gemcitabine vs Gemcitabine + Radiation: p=0.25; Log Rank; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Response [assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3]. Number, participants. Gemcitabine (n=37): 2; Gemcitabine + Radiation (n=34): 2. Analysis, Gemcitabine vs Gemcitabine + Radiation: p=0.99; Fisher Exact; superiority or other legacy.