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Tamoxifen in Treating Patients With Primary Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tamoxifen citrate
Sponsored by
National Medical Research Council (NMRC), Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital
  • University of Udayana
  • Universiti Kebangsaan Malaysia
  • Wellington Cancer Centre
  • National Cancer Institute - Karachi
  • Nishtar Medical College, Multan
  • Tan Tock Seng Hospital
  • National Cancer Centre - Singapore

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 25, 2013
Sponsor
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00003424
Brief Title
Tamoxifen in Treating Patients With Primary Liver Cancer
Official Title
Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
June 2000 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Medical Research Council (NMRC), Singapore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Study Chair
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
University of Udayana
City
Sanglah, Denpasar
State/Province
Bali
Country
Indonesia
Facility Name
Universiti Kebangsaan Malaysia
City
Bangi
ZIP/Postal Code
43600
Country
Malaysia
Facility Name
Wellington Cancer Centre
City
Wellington
ZIP/Postal Code
6039
Country
New Zealand
Facility Name
National Cancer Institute - Karachi
City
Karachi
Country
Pakistan
Facility Name
Nishtar Medical College, Multan
City
Multan
Country
Pakistan
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
1130
Country
Singapore
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

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Tamoxifen in Treating Patients With Primary Liver Cancer

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