Trials / Completed
CompletedNCT00003685
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- NCIC Clinical Trials Group · Network
- Sex
- All
- Age
- 16 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | fatigue assessment and management | |
| PROCEDURE | nausea and vomiting therapy | |
| PROCEDURE | pain therapy | |
| PROCEDURE | quality-of-life assessment | |
| RADIATION | radiation therapy |
Timeline
- Start date
- 1997-08-01
- Primary completion
- 2001-03-01
- Completion
- 2009-02-10
- First posted
- 2004-05-20
- Last updated
- 2020-04-03
Locations
21 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00003685. Inclusion in this directory is not an endorsement.