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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by University of Jena
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01201096
First received: September 13, 2010
Last updated: September 22, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Liver
Metastasis
Neuroendocrine Tumors
Radiation: 177Lutetium
Procedure: Liver transplantation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • tumor free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201096

Contacts
Contact: Christine Wurst, Dr. med. 00493641 ext 9322450 christine.wurst@med.uni-jena.de
Contact: Utz Settmacher, Prof. Dr. med 00493641 ext 9322601 AVG@med.uni-jena.de

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

Additional Information:
No publications provided

Responsible Party: Dr. med. Christine Wurst, Department of General-, Visceral- and Vascularsurgery, University of Jena
ClinicalTrials.gov Identifier: NCT01201096     History of Changes
Other Study ID Numbers: NEO-LEBE
Study First Received: September 13, 2010
Last Updated: September 22, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
neuroendocrine tumor
liver metastasis
peptide receptor therapy
gastro-entero-pancreatic system

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neuroendocrine Tumors
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 20, 2014