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Sponsors and Collaborators: |
University Hospital Freiburg German Federal Ministry of Education and Research Deutsche Krebshilfe e.V., Bonn (Germany) Novartis |
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Information provided by: | University Hospital Freiburg |
ClinicalTrials.gov Identifier: | NCT00386984 |
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.
Condition | Intervention | Phase |
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Carcinoma, Hepatocellular |
Drug: Somatostatin (octreotide) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma |
Estimated Enrollment: | 108 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General:
Study- and indication-specific exclusion criteria:
Germany, Baden-Württemberg | |
University Medical Center Freiburg | |
Freiburg, Baden-Württemberg, Germany, 79106 |
Principal Investigator: | Hans-Peter Allgaier, PD | Evangelischen Diakoniekrankenhaus |
Study ID Numbers: | S 980916 |
Study First Received: | October 11, 2006 |
Last Updated: | October 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00386984 |
Health Authority: | Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Ethikkommission; Switzerland: Federal Office of Public Health |
hepatocellular carcinoma; Sandostatin-LAR; RCT |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Octreotide Somatostatin Carcinoma |
Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Hormones Pharmacologic Actions |