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


Phase 3
18 Years
85 Years
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

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


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?


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

survival time

Principal Investigator

Christian Mueller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaetsklinik fuer Innere Medizin IV

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

HCC-327-2000

NCT ID:

NCT00121914

Start Date:

October 2000

Completion Date:

July 2005

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma, Hepatocellular,
  • percutaneous ethanol instillation
  • long-acting somatostatin
  • Carcinoma
  • Carcinoma, Hepatocellular

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