NCT00041275

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2002

Longer than P75 for phase_3

Geographic Reach
10 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2002

Enrollment Period

5.1 years

First QC Date

July 8, 2002

Last Update Submit

September 19, 2013

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver canceradvanced adult primary liver canceradult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Survival measured weekly

Secondary Outcomes (1)

  • Quality of life as measured by EORTC quality of life instrument monthly

Interventions

megestrol acetateDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

Yangon General Hospital

Yangon, Burma

Location

Rumah Sakit Sanglah

Denpasar, Bali, 20114, Indonesia

Location

Auckland City Hospital

Auckland, 5, New Zealand

Location

Davao Doctors Hospital

Davao City, Philippines

Location

National Cancer Centre - Singapore

Singapore, 169608, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

St. Vincent Hospital

Suwon, 442-060, South Korea

Location

Chang-Gung Memorial Hospital - Taipei

Taipei, 333, Taiwan

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

National Cancer Institute

Hà Nội, Vietnam

Location

Cho Ray Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 21863030RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pierce Chow, MD, PhD, MBBS, FRCS, FAMS

    National Cancer Centre, Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 28, 2003

Study Start

May 1, 2002

Primary Completion

June 1, 2007

Study Completion

August 1, 2011

Last Updated

September 20, 2013

Record last verified: 2002-09

Locations

SG(2)TH(1)BU(1)PH(1)NZ(1)VN(2)TW(1)KR(1)BA(1)ID(1)