Pain Clinical Trial
Official title:
A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung
cancer. It is not yet known which regimen of radiation therapy is most effective in relieving
symptoms in patients with non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of
radiation therapy to relieve symptoms in patients who have 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.
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