Tamoxifen in Treating Patients With Primary Liver Cancer

Phase 3

Completed

• Conditions: Liver Cancer

• Registration Number: NCT00003424
• Lead Sponsor: National Medical Research Council (NMRC), Singapore

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.

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.

Study Timeline

• Study Start: 1997-04
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-06
• Study First Submitted QC: 2004-08-03
• Study First Posted: 2004-08-04
• Status Verified: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

University of Udayana; 🇮🇩 Sanglah, Denpasar, Bali, Indonesia

Wellington Cancer Centre; 🇳🇿 Wellington, New Zealand

Universiti Kebangsaan Malaysia; 🇲🇾 Bangi, Malaysia

National Cancer Institute - Karachi; 🇵🇰 Karachi, Pakistan

Nishtar Medical College, Multan; 🇵🇰 Multan, Pakistan

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

National Cancer Centre - Singapore; 🇸🇬 Singapore, Singapore

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong