Clinical trial NCT00386984: Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: hepatocellular carcinoma; Sandostatin-LAR; RCT
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Deutsche Krebshilfe e.V., Bonn (Germany)
name: Novartis
First posted: 2006-10-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival time
Secondary outcomes:
measure: Costs of the treatment measured by days of in-patient treatment
measure: Side effects
measure: Patient compliance
measure: Quality of life
measure: Somatostatin receptors in the tumor tissue
measure: Prognostic relevance of the Somatostatin receptors
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
state: Baden-Württemberg
Study officials:
affiliation: Evangelischen Diakoniekrankenhaus
name: Hans-Peter Allgaier, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.