Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Deutsche Krebshilfe e.V., Bonn (Germany)
Novartis
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00386984
First received: October 11, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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
Carcinoma, Hepatocellular
Drug: Somatostatin (octreotide)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Overall survival time

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 108
Study Start Date: October 1999
Estimated Study Completion Date: February 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable patients
  • histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA).
  • Age: 18 years or older

Exclusion Criteria:

General:

  • Patient with symptomatic Cholecyst-/Choledocholithiasis
  • Patient with severe psychiatric disease.
  • Participation in another clinical trial within the last 4 weeks.
  • Simultaneous participation in another clinical examination.
  • Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study.
  • Continuous drug or alcohol abuse.
  • Patient with known HIV infection and antiretroviral therapy.
  • Patient with not controllable infection disease.
  • Pregnancy.

Study- and indication-specific exclusion criteria:

  • Secondary malignant tumor without complete remission.
  • Secondary malignant tumor with complete remission but current adjuvant therapy.
  • Preliminary or current therapy with tamoxifen
  • Pretreatment of the HCC.
  • First-time diagnosis > 6 months before inclusion into the study.
  • Severe hepatic encephalopathy, refractory to any treatment.
  • Patients with operable HCC.
  • Contraindication to i.m. injections.
  • Hypersensitivity to octreotide.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386984

Locations
Germany
University Medical Center Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
German Federal Ministry of Education and Research
Deutsche Krebshilfe e.V., Bonn (Germany)
Novartis
Investigators
Principal Investigator: Hans-Peter Allgaier, PD Evangelischen Diakoniekrankenhaus
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00386984     History of Changes
Other Study ID Numbers: S 980916
Study First Received: October 11, 2006
Last Updated: October 11, 2006
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health

Keywords provided by University Hospital Freiburg:
hepatocellular carcinoma; Sandostatin-LAR; RCT

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Octreotide
Somatostatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014