Clinical trial NCT01201096: 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)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver
Metastasis
Neuroendocrine Tumors
Keywords: neuroendocrine tumor
liver metastasis
peptide receptor therapy
gastro-entero-pancreatic system
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: tumor free survival
timeFrame: 5 years
Secondary outcomes:
measure: quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Center for neuroendokrine tumors, Zentralklinik Bad Berka
state: Thüringen
city: Jena
country: Germany
facility: Department of general-, visceral- and vascular surgery, University of Jena
state: Thüringen
Study officials:
affiliation: Department of general-, visceral- and vascular surgery, University of Jena
name: Christine Wurst, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zentrum für neuroendokrine Tumore, Zentralklinik Bad Berka
name: Dieter Hörsch, Prof. Dr. med
role: STUDY_DIRECTOR
affiliation: Department of general-, visceral- and vascular surgery, University of Jena
name: Utz Settmacher, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: Center of neuroendocrine tumors, Zentralklinik Bad Berka
name: R. B. Baum, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: