Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

September 19, 2013 updated by: National Medical Research Council (NMRC), Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangabandhu Sheikh Mujib Medical University
  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia, 20114
        • Rumah Sakit Sanglah
  • Korea, Republic of
      • Suwon, Korea, Republic of, 442-060
        • St. Vincent Hospital
  • Myanmar
      • Yangon, Myanmar
        • Yangon General Hospital
  • New Zealand
      • Auckland, New Zealand, 5
        • Auckland City Hospital
  • Philippines
      • Davao City, Philippines
        • Davao Doctors Hospital
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital
      • Singapore, Singapore, 169608
        • National Cancer Centre - Singapore
  • Taiwan
      • Taipei, Taiwan, 333
        • Chang-Gung Memorial Hospital - Taipei
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
  • Vietnam
      • Ha Noi, Vietnam
        • National Cancer Institute
      • Ho Chi Minh City, Vietnam
        • Cho Ray Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival measured weekly

Secondary Outcome Measures

Outcome Measure
Quality of life as measured by EORTC quality of life instrument monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Council (NMRC), Singapore

Investigators

  • Study Chair: Pierce Chow, MD, PhD, MBBS, FRCS, FAMS, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

July 8, 2002

First Submitted That Met QC Criteria

January 27, 2003

First Posted (ESTIMATE)

January 28, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069460
  • NMRC-AHCC02
  • EU-20203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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