Clinical trial NCT00057876
Conditions: Pancreatic Cancer
Keywords: stage III pancreatic cancer adenocarcinoma of the pancreas
Sponsor: Eastern Cooperative Oncology Group
Start date: 2003-08-29; Completion date: 2009-05-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Gemcitabine intervention 2: radiation therapy
Intervention descriptions: intervention 1: Induction: Patients receive the first cycle of gemcitabine 1000 mg/m\^2 intravenously once per week for 6 weeks followed by 1 week rest.

Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m\^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles. intervention 2: Induction: Patients receive gemcitabine 600 mg/m\^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks.

Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.

Protocol documents: