Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003685|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : April 3, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Lung Cancer Nausea and Vomiting Pain Pulmonary Complications Quality of Life||Procedure: fatigue assessment and management Procedure: nausea and vomiting therapy Procedure: pain therapy Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer|
|Actual Study Start Date :||August 1, 1997|
|Actual Primary Completion Date :||March 2001|
|Actual Study Completion Date :||February 10, 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003685
|Study Chair:||Andrea Bezjak, MD, MSC, FRCPC||Princess Margaret Hospital, Canada|