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
1 other identifier
observational
50
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 13, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 23, 2010
September 1, 2010
5 years
September 13, 2010
September 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor free survival
5 years
Secondary Outcomes (1)
quality of life
5 years
Study Arms (1)
peptide radioreceptor therapy and liver transplantation
Interventions
two cycles of 177Lutetium radioreceptor therapy within two month
about 9 month after finishing the receptor therapy liver transplantation takes place
Eligibility Criteria
All patients with liver metastasis of neuroendocrine tumors of the small bowel, colon, pancreas or stomach. Primary tumor removed.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for neuroendokrine tumors, Zentralklinik Bad Berka
Bad Berka, Thuringia, 99437, Germany
Department of general-, visceral- and vascular surgery, University of Jena
Jena, Thuringia, 07743, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2010
First Posted
September 14, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2018
Last Updated
September 23, 2010
Record last verified: 2010-09