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NCT00003424 Clinical Trial

Tamoxifen in Treating Patients With Primary Liver Cancer

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003424
Other study ID # NMRC-AHCC01
Secondary ID CDR0000066444EU-
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated June 25, 2013
Start date April 1997
Est. completion date August 2009

Study information
Verified date August 2009
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date August 2009
Est. primary completion date June 2000
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 90 Years
Eligibility DISEASE CHARACTERISTICS: Histologically or radiologically confirmed inoperable hepatocellular carcinoma Serum alfa-feto protein level at least 500 ug/L OR Positive lipiodol uptake

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

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tamoxifen citrate

Locations
Country Name City State
Hong Kong Prince of Wales Hospital Shatin, New Territories
Indonesia University of Udayana Sanglah, Denpasar Bali
Malaysia Universiti Kebangsaan Malaysia Bangi
New Zealand Wellington Cancer Centre Wellington
Pakistan National Cancer Institute - Karachi Karachi
Pakistan Nishtar Medical College, Multan Multan
Singapore National Cancer Centre - Singapore Singapore
Singapore Tan Tock Seng Hospital Singapore

Sponsors (1)
Lead Sponsor Collaborator
National Medical Research Council (NMRC), Singapore

Countries where clinical trial is conducted

Hong Kong,  Indonesia,  Malaysia,  New Zealand,  Pakistan,  Singapore, 

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