NCT00003424

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_3

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

August 4, 2004

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 26, 2013

Status Verified

August 1, 2009

Enrollment Period

3.2 years

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver canceradvanced adult primary liver canceradult primary hepatocellular carcinoma

Interventions

tamoxifen citrateDRUG

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

University of Udayana

Sanglah, Denpasar, Bali, Indonesia

Location

Universiti Kebangsaan Malaysia

Bangi, 43600, Malaysia

Location

Wellington Cancer Centre

Wellington, 6039, New Zealand

Location

National Cancer Institute - Karachi

Karachi, Pakistan

Location

Nishtar Medical College, Multan

Multan, Pakistan

Location

Tan Tock Seng Hospital

Singapore, 1130, Singapore

Location

National Cancer Centre - Singapore

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Pierce Chow, MD, PhD, MBBS, FRCS, FAMS

    National Cancer Centre, Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 4, 2004

Study Start

April 1, 1997

Primary Completion

June 1, 2000

Study Completion

August 1, 2009

Last Updated

June 26, 2013

Record last verified: 2009-08

Locations

HK(1)ID(1)PA(2)NZ(1)MY(1)SG(2)