Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003424




Registration number
NCT00003424
Ethics application status
Date submitted
1/11/1999
Date registered
4/08/2004
Date last updated
26/06/2013

Titles & IDs
Public title
Tamoxifen in Treating Patients With Primary Liver Cancer
Scientific title
Randomised Trial of Tamoxifen Versus Placebo for the Treatment of Inoperable Hepatocellular Carcinoma
Secondary ID [1] 0 0
CDR0000066444
Secondary ID [2] 0 0
NMRC-AHCC01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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
Minimum age
10 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin, New Territories
Country [2] 0 0
Indonesia
State/province [2] 0 0
Bali
Country [3] 0 0
Malaysia
State/province [3] 0 0
Bangi
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington
Country [5] 0 0
Pakistan
State/province [5] 0 0
Karachi
Country [6] 0 0
Pakistan
State/province [6] 0 0
Multan
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Government body
Name
National Medical Research Council (NMRC), Singapore
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00003424
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS
Address 0 0
National Cancer Centre, Singapore
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00003424