Status:
COMPLETED
Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
German Federal Ministry of Education and Research
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 prel...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
February 1 2003
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00386984
Start Date
October 1 1999
End Date
February 1 2003
Last Update
October 12 2006
Active Locations (1)
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1
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106