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)
Conditions
Liver - Metastasis - Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neoplasm Metastasis - Neuroendocrine Tumors
Conditions: Keywords
neuroendocrine tumor, liver metastasis, peptide receptor therapy, gastro-entero-pancreatic system
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Intervention
Name: 177Lutetium Type: Radiation
Name: Liver transplantation Type: Procedure
Overall Status
Recruiting
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 and following liver transplantation.
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 within 9 month as postmortal or living donor liver transplantation.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Locations
Center for neuroendokrine tumors, Zentralklinik Bad Berka
Bad Berka, Thüringen, Germany
Status: Recruiting
Contact: Dieter Hörsch, PD Dr. med. - 004936458 - dieter.hoersch@zentralklinik.bad-berka.de
Department of general-, visceral- and vascular surgery, University of Jena
Jena, Thüringen, Germany
Status: Recruiting
Contact: Christine Wurst, Dr.med. - 00493641 - christine.wurst@med.uni-jena.de
Start Date
September 2010
Completion Date
September 2018
Sponsors
University of Jena
Source
University of Jena
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page