A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
OBJECTIVES: I. Compare the efficacy of two schedules of radiotherapy in the palliation of
symptoms in patients with non-small cell lung cancer. II. Compare the toxicity of these two
regimens in these patients. III. Compare the quality of life and survival of patients
treated with these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, weight loss in the previous 6 months (no greater than 10% vs greater than 10%), and
performance status (ECOG 0 or 1 vs 2 or 3). Patients are randomized to undergo radiotherapy
as 5 fractions over 5 days or 1 fraction on 1 day. Quality of life is assessed before
treatment, weekly for 5 weeks, and monthly thereafter. Patients are followed weekly for 5
weeks, then every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Andrea Bezjak, MD, MSC, FRCPC
Study Chair
Princess Margaret Hospital, Canada
United States: Federal Government
SC15
NCT00003685
December 1998
February 2009
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