Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041275
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2002-07-08
Brief Title:
Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Sponsor:
National Medical Research Council NMRC Singapore
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2002-09
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 Estrogen can stimulate the growth of cancer cells Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen It is not yet known if megestrol is an effective treatment for liver cancer
PURPOSE Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery
PURPOSE Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo
Compare the quality of life of patients treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral megestrol twice daily for 1 year
Arm II Patients receive an oral placebo twice daily for 1 year Quality of life is assessed at baseline and then monthly for 1 year
PROJECTED ACCRUAL A minimum of 300 patients 200 for arm I and 100 for arm II will be accrued for this study
Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo
Compare the quality of life of patients treated with these drugs
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral megestrol twice daily for 1 year
Arm II Patients receive an oral placebo twice daily for 1 year Quality of life is assessed at baseline and then monthly for 1 year
PROJECTED ACCRUAL A minimum of 300 patients 200 for arm I and 100 for arm II will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20203 | None | None | None |
| NMRC-AHCC02 | None | None | None |