Status:
UNKNOWN
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)
Lead Sponsor:
University of Jena
Conditions:
Liver
Metastasis
Eligibility:
All Genders
18-60 years
Brief Summary
The purpose of this study is to show the tumor free long term survival of patients with isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio receptor treatment an...
Detailed Description
Matching patient will be treated neo-adjuvant at the hospital with 177 Lutetium peptide receptor radiotherapy in two following courses. After this treatment it will follow the liver transplantation wi...
Eligibility Criteria
Inclusion
- Age between 18 to 60 years
- 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
- prognostic relevant second tumor disease
- pregnancy
- undifferentiated neuroendocrine carcinoma (WHO II, G3)
- renal insufficiency \> second degree
- progressive carcinoid conditioned heart disease (\>NYHA II)
- Karnofsky-Index \< 60
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01201096
Start Date
September 1 2010
End Date
September 1 2018
Last Update
September 23 2010
Active Locations (2)
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1
Center for neuroendokrine tumors, Zentralklinik Bad Berka
Bad Berka, Thuringia, Germany, 99437
2
Department of general-, visceral- and vascular surgery, University of Jena
Jena, Thuringia, Germany, 07743