Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Tamoxifen in Treating Patients With Primary Liver Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | 10 to 90 | NMRC-AHCC01 EU-98018, NCT00003424 |
Objectives
I. Assess the therapeutic role of tamoxifen in patients with inoperable hepatocellular carcinoma in terms of overall survival and quality of life.
Entry Criteria
Disease Characteristics:
Histologically or radiologically confirmed inoperable hepatocellular carcinoma Serum alfa-feto protein level at least 500 ug/L OR Positive lipiodol uptake
Prior/Concurrent Therapy:
Biologic therapy: Not specified Chemotherapy: No prior chemoembolization therapy for disease No prior systemic chemotherapy for disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgery for disease Other: No prior percutaneous injection
Patient Characteristics:
Age: 10 to 90 Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.7 mg/dL Other: No encephalopathy
Expected Enrollment
300This 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.
Trial Lead Organizations
NMRC Asia-Pacific Hepatocellular Carcinoma Trials Group
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| Pierce Chow, MD, PhD, MBBS, FRCS, FAMS, Protocol chair | |
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| Registry Information | ||
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| Official Title | Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma | |
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| Trial Start Date | 1997-04-04 | |
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| Trial Completion Date | 2000-06-01 | |
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| Registered in ClinicalTrials.gov | NCT00003424 | |
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| Date Submitted to PDQ | 1998-07-09 | |
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| Information Last Verified | 2009-08-17 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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