Prospektive, randomisized, double-blind, placebo-controlled multicenter phase III-study to evaluate the efficacy of octreotide in patients with inoperable hepatocellular carcinoma
- Conditions
- iver NeoplasmsC22.0Liver cell carcinoma
- Registration Number
- DRKS00000012
- Lead Sponsor
- Gastro-enterologische Abteilung des Universitätsklinikums Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
Inoperable patients with histologically approved 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). The inoperability should be approved by an experienced (transplantation) surgeon and dokumented.
Age: no restriction.
General
- Patient with symptomatic Cholecysto-/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 antiretrovirale therapy.
- Patient with not controllable infection disease.
- Pregnancy.
Study- and indication-specific exclusion criteria
- Secondary malignoma without complete remission.
- Secondary malignoma with complete remission but current adjuvante therapy.
- Preliminary or current therapy with tamoxiphene
- 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival time
- Secondary Outcome Measures
Name Time Method