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)

Study Overview
=================
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 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.

Official Title
-----------------
Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors

Conditions
-----------------
Liver, Metastasis, Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Radiation: 177Lutetium
* Procedure: Liver transplantation


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| peptide radioreceptor therapy and liver transplantation<br> | Radiation: 177Lutetium<br>* two cycles of 177Lutetium radioreceptor therapy within two month<br>Procedure: Liver transplantation<br>* about 9 month after finishing the receptor therapy liver transplantation takes place<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroendocrine tumor, liver metastasis, peptide receptor therapy, gastro-entero-pancreatic system