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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00041275




Registration number
NCT00041275
Ethics application status
Date submitted
8/07/2002
Date registered
28/01/2003
Date last updated
20/09/2013

Titles & IDs
Public title
Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Scientific title
Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
Secondary ID [1] 0 0
NMRC-AHCC02
Secondary ID [2] 0 0
CDR0000069460
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
Primary outcome [1] 0 0
Survival measured weekly
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Quality of life as measured by EORTC quality of life instrument monthly
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Diagnosis of hepatocellular carcinoma (HCC)

* Histologically confirmed OR
* Meets 2 of the following criteria:

* Radiological evidence of HCC on CT scan, MRI, or ultrasound
* Serum alpha-fetoprotein level at least 400 µg/L
* Positive lipiodol retention
* Not amenable to surgery

PATIENT CHARACTERISTICS:

Age:

* 20 to 100

Performance status:

* ECOG 0-3

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 5.8 mg/dL

Renal:

* Creatinine less than 1.7 mg/dL

Other:

* Not pregnant
* No clinical encephalopathy
* No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemoembolization for HCC
* No prior systemic chemotherapy for HCC

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
* No prior surgery for HCC

Other:

* No prior percutaneous injection for HCC
Minimum age
20 Years
Maximum age
No limit
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
1/05/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bangladesh
State/province [1] 0 0
Dhaka
Country [2] 0 0
Indonesia
State/province [2] 0 0
Bali
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Suwon
Country [4] 0 0
Myanmar
State/province [4] 0 0
Yangon
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
Philippines
State/province [6] 0 0
Davao City
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taipei
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok
Country [10] 0 0
Vietnam
State/province [10] 0 0
Ha Noi
Country [11] 0 0
Vietnam
State/province [11] 0 0
Ho Chi Minh City

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 megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.
Trial website
https://clinicaltrials.gov/study/NCT00041275
Trial related presentations / publications
Chow PK, Machin D, Chen Y, Zhang X, Win KM, Hoang HH, Nguyen BD, Jin MY, Lobo R, Findlay M, Lim CH, Tan SB, Gandhi M, Soo KC; Asia-Pacific Hepatocellular Carcinoma Trials Group. Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma. Br J Cancer. 2011 Sep 27;105(7):945-52. doi: 10.1038/bjc.2011.333. Epub 2011 Aug 23.
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/NCT00041275