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

October 11, 2006 updated by: University Hospital Freiburg

Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • University Medical Center Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival time

Secondary Outcome Measures

Outcome Measure
Quality of life
Side effects
Patient compliance
Costs of the treatment measured by days of in-patient treatment
Somatostatin receptors in the tumor tissue
Prognostic relevance of the Somatostatin receptors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Collaborators

Novartis
German Federal Ministry of Education and Research
Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

  • Principal Investigator: Hans-Peter Allgaier, PD, Evangelischen Diakoniekrankenhaus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Completion

February 1, 2003

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 12, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2006

Last Update Submitted That Met QC Criteria

October 11, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S 980916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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