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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

October 11, 2006
October 11, 2006
October 1999
Not Provided
Overall survival time
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Drug: Somatostatin (octreotide)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
February 2003
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00386984
S 980916
Not Provided
Not Provided
University Hospital Freiburg
  • German Federal Ministry of Education and Research
  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • Novartis
Principal Investigator: Hans-Peter Allgaier, PD Evangelischen Diakoniekrankenhaus
University Hospital Freiburg
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP