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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)

This study is currently recruiting participants.
Verified September 2010 by University of Jena
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201096
First Posted: September 14, 2010
Last Update Posted: September 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
University of Jena
September 13, 2010
September 14, 2010
September 23, 2010
September 2010
September 2015   (Final data collection date for primary outcome measure)
tumor free survival [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01201096 on ClinicalTrials.gov Archive Site
quality of life [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
 
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-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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All patients with liver metastasis of neuroendocrine tumors of the small bowel, colon, pancreas or stomach. Primary tumor removed.
  • Liver
  • Metastasis
  • Neuroendocrine Tumors
  • 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
peptide radioreceptor therapy and liver transplantation
Interventions:
  • Radiation: 177Lutetium
  • Procedure: Liver transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
September 2018
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
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
Germany
 
 
NCT01201096
NEO-LEBE
No
Not Provided
Not Provided
Dr. med. Christine Wurst, Department of General-, Visceral- and Vascularsurgery, University of Jena
University of Jena
Not Provided
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
University of Jena
September 2010