Clinical trial · Interventional
Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma
NCT00041275CI-TRIAL-00012226completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| megestrol acetate | Drug | Megestrol | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival measured weekly
Secondary outcomes (1)
- measure
- Quality of life as measured by EORTC quality of life instrument monthly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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 HCCReferences
Publications (1)
- RESULTChow 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 21863030