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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01201096
Other study ID # NEO-LEBE
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 2010
Last updated September 22, 2010
Start date September 2010
Est. completion date September 2018

Study information

Verified date September 2010
Source University of Jena
Contact Christine Wurst, Dr. med.
Phone 00493641
Email christine.wurst@med.uni-jena.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2018
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
Germany Center for neuroendokrine tumors, Zentralklinik Bad Berka Bad Berka Thüringen
Germany Department of general-, visceral- and vascular surgery, University of Jena Jena Thüringen

Sponsors (1)

Lead Sponsor Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary tumor free survival 5 years No
Secondary quality of life 5 years No
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