Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003424
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Tamoxifen in Treating Patients With Primary Liver Cancer
Sponsor:
National Medical Research Council NMRC Singapore
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-08
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 tamoxifen may fight liver cancer by blocking the absorption of estrogen It is not yet known whether receiving tamoxifen is more effective than no further therapy in treating patients with primary liver cancer
PURPOSE Randomized phase III trial to compare high-dose tamoxifen with no further treatment in treating patients with liver cancer that cannot be surgically removed
PURPOSE Randomized phase III trial to compare high-dose tamoxifen with no further treatment in treating patients with liver cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Assess the therapeutic role of tamoxifen in patients with inoperable hepatocellular carcinoma in terms of overall survival and quality of life
OUTLINE This is a randomized double blind placebo controlled study of tamoxifen Patients are randomized to one of 3 treatment arms Arm I Patients receive placebo orally twice daily for one year Arms II and III Patients receive tamoxifen at 1 of 2 different doses orally twice daily for one year Quality of life is assessed before treatment and then monthly thereafter Patients are followed monthly until death
PROJECTED ACCRUAL This study will accrue 300 patients
OUTLINE This is a randomized double blind placebo controlled study of tamoxifen Patients are randomized to one of 3 treatment arms Arm I Patients receive placebo orally twice daily for one year Arms II and III Patients receive tamoxifen at 1 of 2 different doses orally twice daily for one year Quality of life is assessed before treatment and then monthly thereafter Patients are followed monthly until death
PROJECTED ACCRUAL This study will accrue 300 patients
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 |
|---|---|---|---|
| EU-98018 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066444 | REGISTRY | None | None |