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Phase III Randomized Study of High Dose Tamoxifen versus Placebo in Patients with Inoperable Hepatocellular Carcinoma (Summary Last Modified 07/2000)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Tamoxifen in Treating Patients With Primary Liver Cancer

Basic Trial Information

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

300

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.

Trial Contact Information

Trial Lead Organizations

NMRC Asia-Pacific Hepatocellular Carcinoma Trials Group

Pierce Chow, MD, PhD, MBBS, FRCS, FAMS, Protocol chair
Ph: 65-6321-4051
Email: gsupc@sgh.com.sg

Registry Information

Official Title		Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma

Trial Start Date		1997-04-04

Trial Completion Date		2000-06-01

Registered in ClinicalTrials.gov		NCT00003424

Date Submitted to PDQ		1998-07-09

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.