Back to resultsHector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
Primary Purpose
Carcinoma, Hepatocellular
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Somatostatin (octreotide)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring hepatocellular carcinoma; Sandostatin-LAR; RCT
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.
Sites / Locations
- University Medical Center Freiburg
Outcomes
Primary Outcome Measures
Overall survival time
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00386984
First Posted
October 11, 2006
Last Updated
October 11, 2006
Sponsor
University Hospital Freiburg
Collaborators
German Federal Ministry of Education and Research, Deutsche Krebshilfe e.V., Bonn (Germany), Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00386984
Brief Title
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
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Freiburg
Collaborators
German Federal Ministry of Education and Research, Deutsche Krebshilfe e.V., Bonn (Germany), Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
hepatocellular carcinoma; Sandostatin-LAR; RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Somatostatin (octreotide)
Primary Outcome Measure Information:
Title
Overall survival time
Secondary Outcome Measure Information:
Title
Costs of the treatment measured by days of in-patient treatment
Title
Side effects
Title
Patient compliance
Title
Quality of life
Title
Somatostatin receptors in the tumor tissue
Title
Prognostic relevance of the Somatostatin receptors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Peter Allgaier, PD
Organizational Affiliation
Evangelischen Diakoniekrankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
10761474
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.
Results Reference
result
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Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
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