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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peptide radioreceptor therapy and liver transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lutetium | Radiation | two cycles of 177Lutetium radioreceptor therapy within two month |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with liver metastasis of neuroendocrine tumors of the small bowel, colon, pancreas or stomach. Primary tumor removed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Wurst, Dr. med. | Contact | 00493641 | 9322450 | christine.wurst@med.uni-jena.de |
| Utz Settmacher, Prof. Dr. med | Contact | 00493641 | 9322601 | AVG@med.uni-jena.de |
| Name | Affiliation | Role |
|---|---|---|
| Christine Wurst, Dr. med. | Department of general-, visceral- and vascular surgery, University of Jena | Principal Investigator |
| Dieter Hörsch, Prof. Dr. med | Zentrum für neuroendokrine Tumore, Zentralklinik Bad Berka |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for neuroendokrine tumors, Zentralklinik Bad Berka | Recruiting | Bad Berka | Thuringia | 99437 | Germany |
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| Liver transplantation | Procedure | about 9 month after finishing the receptor therapy liver transplantation takes place |
|
| Utz Settmacher, Prof. Dr. med. | Department of general-, visceral- and vascular surgery, University of Jena | Study Chair |
| R. B. Baum, Prof.Dr.med. | Center of neuroendocrine tumors, Zentralklinik Bad Berka | Principal Investigator |
| Department of general-, visceral- and vascular surgery, University of Jena | Recruiting | Jena | Thuringia | 07743 | Germany |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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