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


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival time

Principal Investigator

Hans-Peter Allgaier, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Evangelischen Diakoniekrankenhaus

Authority:

Germany: Ethics Commission

Study ID:

S 980916

NCT ID:

NCT00386984

Start Date:

October 1999

Completion Date:

February 2003

Related Keywords:

  • Carcinoma, Hepatocellular
  • hepatocellular carcinoma; Sandostatin-LAR; RCT
  • Carcinoma
  • Carcinoma, Hepatocellular

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