Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
NCT ID: NCT00041275
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2002-05-31
2011-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo.
* Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral megestrol twice daily for 1 year.
* Arm II: Patients receive an oral placebo twice daily for 1 year. Quality of life is assessed at baseline and then monthly for 1 year.
PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
megestrol acetate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Medical Research Council (NMRC), Singapore
OTHER_GOV
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierce Chow, MD, PhD, MBBS, FRCS, FAMS
Role: STUDY_CHAIR
National Cancer Centre, Singapore
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bangabandhu Sheikh Mujib Medical University
Dhaka, , Bangladesh
Yangon General Hospital
Yangon, , Burma
Rumah Sakit Sanglah
Denpasar, Bali, Indonesia
Auckland City Hospital
Auckland, , New Zealand
Davao Doctors Hospital
Davao City, , Philippines
National Cancer Centre - Singapore
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
St. Vincent Hospital
Suwon, , South Korea
Chang-Gung Memorial Hospital - Taipei
Taipei, , Taiwan
Ramathibodi Hospital
Bangkok, , Thailand
National Cancer Institute
Hà Nội, , Vietnam
Cho Ray Hospital
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NMRC-AHCC02
Identifier Type: -
Identifier Source: secondary_id
EU-20203
Identifier Type: -
Identifier Source: secondary_id
CDR0000069460
Identifier Type: -
Identifier Source: org_study_id