Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031785
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2002-03-08
Brief Title:
Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Double-Blind Randomized Study of the Effect of Megestrol Acetate on Weight and Health Related Quality of Life in Lung Cancer Patients Receiving Thoracic Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2021-09
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 Megestrol helps improve appetite It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer
Detailed Description:
OBJECTIVES
Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer
Determine the quality of life of patients treated with this drug
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to histology non-small cell lung cancer vs small cell lung cancer and type of treatment radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy Patients are randomized to one of two treatment arms
All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks
Arm I Patients receive oral megestrol once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy
Arm II Patients receive oral placebo once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy
In both arms quality of life is assessed at baseline at the completion of radiotherapy and at 4 8 12 16 and 20 weeks after the completion of radiotherapy
Patients are followed at 4 and 8 weeks
PROJECTED ACCRUAL A total of 98 patients 49 per treatment arm will be accrued for this study
Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer
Determine the quality of life of patients treated with this drug
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to histology non-small cell lung cancer vs small cell lung cancer and type of treatment radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy Patients are randomized to one of two treatment arms
All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks
Arm I Patients receive oral megestrol once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy
Arm II Patients receive oral placebo once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy
In both arms quality of life is assessed at baseline at the completion of radiotherapy and at 4 8 12 16 and 20 weeks after the completion of radiotherapy
Patients are followed at 4 and 8 weeks
PROJECTED ACCRUAL A total of 98 patients 49 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-P02-0210 | None | None | None |
| CCCWFU-98199 | None | None | None |