Completed

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

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What is being tested

tamoxifen citrate

Drug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 10 to 90 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorNational Medical Research Council (NMRC), Singapore
Last updated: June 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00003424
Principal SponsorNational Medical Research Council (NMRC), Singapore
Last updated: June 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsLiver DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialCarcinoma, HepatocellularLiver Neoplasms

Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Prince of Wales Hospital

Shatin, New Territories, Hong KongOpen Prince of Wales Hospital in Google Maps

University of Udayana

Sanglah, Denpasar, Indonesia

Universiti Kebangsaan Malaysia

Bangi, Malaysia

Wellington Cancer Centre

Wellington, New Zealand
Completed8 Study Centers