Liver CancerPhase 3NCT00003424
Tamoxifen in Treating Patients With Primary Liver Cancer
A Phase 3 study testing tamoxifen citrate in people with Liver Cancer, run by National Medical Research Council (NMRC), Singapore at 8 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- tamoxifen citrate
- How many people
- 300 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Apr 1997to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Pakistan2 sites
National Cancer Institute - Karachi
Karachi
Nishtar Medical College, Multan
Multan
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 1130
National Cancer Centre - Singapore
Singapore, 169608
About this study
Official title: Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- tamoxifen citrate
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifen citrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2004 (estimated)
- Study startApr 1997
- Primary completionJun 2000
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Council (NMRC), Singapore
- Sponsor type
- Other government
- Investigators
- Pierce Chow, MD, PhD, MBBS, FRCS, FAMS, Study chair, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003424
- Sponsor's protocol ID
- NMRC-AHCC01
- Other IDs
- CDR0000066444, EU-98018
- Status last verified
- Aug 2009
- First submitted
- 1 Nov 1999
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00003424
- Acronym / sponsor ID
- NMRC-AHCC01
- Conditions
- Liver Cancer
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Medical Research Council (NMRC), SingaporeOther government
- Study start
- Apr 1997
- Primary completion
- Jun 2000 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifen citrate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS study chair
National Cancer Centre, Singapore
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamoxifen citrate in people with Liver Cancer, run by National Medical Research Council (NMRC), Singapore at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Pakistan, Singapore, Hong Kong, Indonesia, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.