Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatment percutaneous ethanol instillation (pei)
Phase phase 3
Sponsor Medical University of Vienna
Start date October 2000
End date July 2005
Trial size 120 participants
Trial identifier NCT00121914, HCC-327-2000

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
survival time
time frame:
time to tumour progression
time frame:

Secondary Outcomes

Measure
quality of life
time frame:
causes of death
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone
Principal investigator Christian Mueller, MD
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?
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by Medical University of Vienna.