Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma|
- Overall survival time
- Costs of the treatment measured by days of in-patient treatment
- Side effects
- Patient compliance
- Quality of life
- Somatostatin receptors in the tumor tissue
- Prognostic relevance of the Somatostatin receptors
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||February 2003|
A pilot study showed that octreotide can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the Somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma.
An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.
|University Medical Center Freiburg|
|Freiburg, Baden-Württemberg, Germany, 79106|
|Principal Investigator:||Hans-Peter Allgaier, PD||Evangelischen Diakoniekrankenhaus|