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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2003-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Hepatocellular

Keywords

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hepatocellular carcinoma; Sandostatin-LAR; RCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Somatostatin (octreotide)

Intervention Type DRUG

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hans-Peter Allgaier, PD

Role: PRINCIPAL_INVESTIGATOR

Evangelischen Diakoniekrankenhaus

Locations

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University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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. No abstract available. German.

Reference Type RESULT

PMID: 10761474 (View on PubMed)

Other Identifiers

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S 980916

Identifier Type: -

Identifier Source: org_study_id