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
• Interventions: Radiation: 177Lutetium; Procedure: Liver transplantation

• Registration Number: NCT01201096
• Lead Sponsor: University of Jena

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Last Update Submitted: 2010-09-22
• Last Update Posted: 2010-09-23
• Primary Completion: 2015-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
peptide radioreceptor therapy and liver transplantation	177Lutetium	-
peptide radioreceptor therapy and liver transplantation	Liver transplantation	-

Primary Outcome Measures

Name	Time	Method
tumor free survival	5 years

Secondary Outcome Measures

Name	Time	Method
quality of life	5 years

Trial Locations

Locations (2)

Center for neuroendokrine tumors, Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Thüringen, Germany

Department of general-, visceral- and vascular surgery, University of Jena; 🇩🇪 Jena, Thüringen, Germany