Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Carcinoma, Hepatocellular Clinical Trial

Official title:

Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00121914
• Other study ID #: HCC-327-2000
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 15, 2005
• Last updated: October 17, 2005
• Start date: October 2000
• Est. completion date: July 2005

Study information

• Verified date: July 2005
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly [i.m.]) and will be randomized for treatment with PEI or no additional treatment.

Description:

This is a randomized two-arm parallel group study.

• Study group: PEI + long-acting somatostatin

• Control group: long-acting somatostatin alone

Aims of the study:

• Does treatment with PEI+ long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone?

• Can time to tumour progression be extended in patients treated with PEI + long-acting somatostatin as compared to treatment with long-acting somatostatin alone?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Histologically-proven hepatocellular carcinoma

• Treatable with percutaneous ethanol instillation

• Inoperable tumour

• Age 18-85 years

Exclusion Criteria:

• Liver cirrhosis Child C

• Tumour diameter > 8 cm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Procedure:
• percutaneous ethanol instillation (PEI)

Locations

Country	Name	City	State
Austria	Universitaetsklinik fuer Innere Medizin IV / Gastroenterologie und Hepatologie	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival time
Primary	time to tumour progression
Secondary	quality of life
Secondary	causes of death