Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003685
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-SC15 | OTHER | None | None |
| CDR0000066787 | OTHER | PDQ | None |