Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Overall survival time
Hans-Peter Allgaier, PD
Germany: Ethics Commission