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

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)

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.

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.

Liver
Metastasis
Neuroendocrine Tumors

RADIATION: 177Lutetium
PROCEDURE: Liver transplantation

NEO-LEBE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-09-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-09-22
First Submitted that Met QC Criteria 2010-09-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-09-23
First Posted (ESTIMATED) 2010-09-14	Results First Posted N/A	Last Verified 2010-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: peptide radioreceptor therapy and liver transplantation	RADIATION: 177Lutetium two cycles of 177Lutetium radioreceptor therapy within two month PROCEDURE: Liver transplantation about 9 month after finishing the receptor therapy liver transplantation takes place

Participant Group/Arm

Intervention/Treatment

: peptide radioreceptor therapy and liver transplantation

RADIATION: 177Lutetium

two cycles of 177Lutetium radioreceptor therapy within two month

PROCEDURE: Liver transplantation

about 9 month after finishing the receptor therapy liver transplantation takes place

Primary Outcome Measures	Measure Description	Time Frame
tumor free survival		5 years

Secondary Outcome Measures	Measure Description	Time Frame
quality of life		5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Christine Wurst, Dr. med.

Phone Number: 00493641

Email: christine.wurst@med.uni-jena.de

Study Contact Backup

Name: Utz Settmacher, Prof. Dr. med

Phone Number: 00493641

Email: AVG@med.uni-jena.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Christine Wurst, Dr. med., Department of general-, visceral- and vascular surgery, University of Jena

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record