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

Carcinoma, Hepatocellular Clinical Trial

Official title:

Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386984
• Other study ID #: S 980916
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2006
• Last updated: October 11, 2006
• Start date: October 1999
• Est. completion date: February 2003

Study information

• Verified date: October 2006
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesSwitzerland: EthikkommissionSwitzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Somatostatin (octreotide)

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg	Freiburg	Baden-Württemberg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Freiburg	Deutsche Krebshilfe e.V., Bonn (Germany), German Federal Ministry of Education and Research, Novartis

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time
Secondary	Costs of the treatment measured by days of in-patient treatment
Secondary	Side effects
Secondary	Patient compliance
Secondary	Quality of life
Secondary	Somatostatin receptors in the tumor tissue
Secondary	Prognostic relevance of the Somatostatin receptors