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)

Neuroendocrine Tumors Clinical Trial

— NEO-LEBE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01201096
• Other study ID #: NEO-LEBE
• 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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Liver
• Metastasis
• Neoplasm Metastasis
• Neuroendocrine Tumors

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

External Links

•   official site of the department of general-, visceral- and vascular surgery, University of Jena