Liver, Metastasis, Neuroendocrine Tumors
Conditions
Keywords
neuroendocrine tumor, liver metastasis, peptide receptor therapy, gastro-entero-pancreatic system
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.
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.
Interventions
RADIATION177Lutetium
two cycles of 177Lutetium radioreceptor therapy within two month
PROCEDURELiver transplantation
about 9 month after finishing the receptor therapy liver transplantation takes place
Sponsors
University of Jena
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor free survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | 5 years |
Countries
Germany
Contacts
Primary ContactChristine Wurst, Dr. med.
Backup ContactUtz Settmacher, Prof. Dr. med
Outcome results
None listed