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) (NEO-LEBE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Neuroendocrine Tumors; Metastasis; Liver
• Intervention / Treatment: Radiation: 177Lutetium; Procedure: 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Germany
  • Thüringen
    • Bad Berka, Thüringen, Germany, 99437
      • Recruiting
      • Center for neuroendokrine tumors, Zentralklinik Bad Berka
      • Contact: Dieter Hörsch, PD Dr. med.; Phone Number: 52601 004936458; Email: dieter.hoersch@zentralklinik.bad-berka.de
      • Contact: R. P. Baum, Prof.Dr.med.; Phone Number: 53515 004936458; Email: r.baum.pet@zentralklinik-bad-berka.de
      • Principal Investigator: Dieter Hoersch, Prof. Dr. med
    • Jena, Thüringen, Germany, 07743
      • Recruiting
      • Department of general-, visceral- and vascular surgery, University of Jena
      • Contact: Christine Wurst, Dr.med.; Phone Number: 9322450 00493641; Email: christine.wurst@med.uni-jena.de
      • Contact: Utz Settmacher, Prof.Dr. med; Phone Number: 9322601 00493641; Email: AVG@med.uni-jena.de
      • Principal Investigator: Christine Wurst, Dr.med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with liver metastasis of neuroendocrine tumors of the small bowel, colon, pancreas or stomach. Primary tumor removed.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
tumor free survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life	5 years

Collaborators and Investigators

• Sponsor: University of Jena
• Investigators: Principal Investigator: Christine Wurst, Dr. med., Department of general-, visceral- and vascular surgery, University of Jena; Study Director: Dieter Hörsch, Prof. Dr. med, Zentrum für neuroendokrine Tumore, Zentralklinik Bad Berka; Study Chair: Utz Settmacher, Prof. Dr. med., Department of general-, visceral- and vascular surgery, University of Jena; Principal Investigator: R. B. Baum, Prof.Dr.med., Center of neuroendocrine tumors, Zentralklinik Bad Berka

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 23, 2010
• Last Update Submitted That Met QC Criteria: September 22, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: liver metastasis; neuroendocrine tumor; peptide receptor therapy; gastro-entero-pancreatic system
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neoplasm Metastasis; Neuroendocrine Tumors
• Other Study ID Numbers: NEO-LEBE