Liver CancerPhase 3NCT00041275
Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
A Phase 3 study testing megestrol acetate in people with Liver Cancer, run by National Medical Research Council (NMRC), Singapore at 12 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- megestrol acetate
- How many people
- 300 participants
- Where
- 12 sitesin 10 countries
- Study dates
- May 2002to Aug 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
12 sites in 10 countries.
12 sites in 10 countries
Singapore2 sites
National Cancer Centre - Singapore
Singapore, 169608
Changi General Hospital
Singapore, 529889
Vietnam2 sites
National Cancer Institute
Hà Nội
Cho Ray Hospital
Ho Chi Minh City
About this study
Official title: Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
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.
Read the detailed description
OBJECTIVES:
- 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
- Liver Cancer
- Being tested
- megestrol acetate
- 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.
megestrol acetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival measured weekly
Secondary outcomes (1)
Quality of life as measured by EORTC quality of life instrument monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionJun 2007
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- 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
- NCT00041275
- Sponsor's protocol ID
- CDR0000069460
- Other IDs
- NMRC-AHCC02, EU-20203
- Status last verified
- Sep 2002
- First submitted
- 8 Jul 2002
- Last updated
- 20 Sep 2013
- Results posted
- No
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.
PubMed 21863030
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00041275
- Acronym / sponsor ID
- CDR0000069460
- 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
- May 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Jan 2003 (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 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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| megestrol acetate | Drug | – |
Primary outcome
Survival measured weekly
1 secondary outcome
Quality of life as measured by EORTC quality of life instrument monthly
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 20 Sep 2013.
- Results publication: PubMed 21863030Chow 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.
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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
12 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing megestrol acetate in people with Liver Cancer, run by National Medical Research Council (NMRC), Singapore at 12 sites in 10 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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Singapore, Vietnam, Bangladesh, Burma, Indonesia and 5 more countries. 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.
What does the primary outcome measure?
Survival measured weekly. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041275, which also lists 1 linked publication.
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 20 Sep 2013.