Trial document




This trial has been registered retrospectively.
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  DRKS00000012

Trial Description

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Title

Prospektive, randomisized, double-blind, placebo-controlled multicenter phase III-study to evaluate the efficacy of octreotide in patients with inoperable hepatocellular carcinoma

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Trial Acronym

Hector-Studie

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URL of the Trial

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Brief Summary in Lay Language

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 Octreotid 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.

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Brief Summary in Scientific Language

A pilot study showed that Octreotid can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evalueted by comparison of Octreotid 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 hepatozellular carcinoma.
An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.

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Organizational Data

  •   DRKS00000012
  •   2008/09/05
  •   2005/09/14
  •   no
  •   Approved
  •   240/98, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   NCT00386984  (ClinicalTrials.gov)
  •   UKF000513  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   Liver Neoplasms
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Interventions/Observational Groups

  •   Somatostatin (octreotide)
  •   pseudo-drug (so called placebo)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

Overall survival time

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   1999/10/01
  •   120
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inoperable patients with histologically approved 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). The inoperability should be approved by an experienced (transplantation) surgeon and dokumented.
Age: no restriction.

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Exclusion Criteria

General
- Patient with symptomatic Cholecysto-/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 antiretrovirale therapy.
- Patient with not controllable infection disease.
- Pregnancy.

Study- and indication-specific exclusion criteria
- Secondary malignoma without complete remission.
- Secondary malignoma with complete remission but current adjuvante therapy.
- Preliminary or current therapy with tamoxiphene
- 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.

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Addresses

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    • Gastro-enterologische Abteilung des Universitätsklinikums Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Evangelisches Diakoniekrankenhaus
    • Mr.  Prof. Dr. med.  Hans-Peter  Allgaier 
    • Germany
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Sources of Monetary or Material Support

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    • Novartis Deutschland
    • Roonstraße 25
    • 90429  Nürnberg
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    •   +49 911 27312940
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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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    • Bundesministerium für Bildung und Forschung
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Status

  •   Recruiting complete, follow-up complete
  •   2003/02/28
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Trial Publications, Results and other Documents

  •   Allgaier HP, Becker G, Blum HE. [A therapeutic study of hepatocellular carcinoma using octreotide (HECTOR). Hepatocellular Carcinoma: Treatment with Octreotide] Dtsch Med Wochenschr. 2000 Mar 17;125(11):320. German. No abstract available.
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* This entry means the parameter is not applicable or has not been set.