Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE)
NCT ID: NCT01201096
Last Updated: 2010-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2010-09-30
2018-09-30
Brief Summary
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Detailed Description
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Under certain conditions concerning the evaluation examinations patients can be included in the study.
Most important factors are no evidence of disease outside the liver, removed primary tumor, patients between 18 and 60 years, no curative surgical resection of the liver metastasis possible.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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peptide radioreceptor therapy and liver transplantation
177Lutetium
two cycles of 177Lutetium radioreceptor therapy within two month
Liver transplantation
about 9 month after finishing the receptor therapy liver transplantation takes place
Interventions
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177Lutetium
two cycles of 177Lutetium radioreceptor therapy within two month
Liver transplantation
about 9 month after finishing the receptor therapy liver transplantation takes place
Eligibility Criteria
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Inclusion Criteria
* neuroendocrine Tumor with low or intermediate malignant histological appearance
* primary tumor removed, no extrahepatic tumor
* liver metastasis not resectable
* positive evaluation for liver transplantation
* primary tumor drained by vena porta
* tumor load within the liver \< 50%
* stable disease after receptor therapy with 177 Lutetium for 6 month
Exclusion Criteria
* pregnancy
* undifferentiated neuroendocrine carcinoma (WHO II, G3)
* renal insufficiency \> second degree
* progressive carcinoid conditioned heart disease (\>NYHA II)
* Karnofsky-Index \< 60
18 Years
60 Years
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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Department of General-, Visceral- and Vascularsurgery, University of Jena
Principal Investigators
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Christine Wurst, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of general-, visceral- and vascular surgery, University of Jena
Dieter Hörsch, Prof. Dr. med
Role: STUDY_DIRECTOR
Zentrum für neuroendokrine Tumore, Zentralklinik Bad Berka
Utz Settmacher, Prof. Dr. med.
Role: STUDY_CHAIR
Department of general-, visceral- and vascular surgery, University of Jena
R. B. Baum, Prof.Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Center of neuroendocrine tumors, Zentralklinik Bad Berka
Locations
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Center for neuroendokrine tumors, Zentralklinik Bad Berka
Bad Berka, Thuringia, Germany
Department of general-, visceral- and vascular surgery, University of Jena
Jena, Thuringia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEO-LEBE
Identifier Type: -
Identifier Source: org_study_id