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)
This study is currently recruiting participants.
Verified September 2010 by University of Jena
Sponsor:
University of Jena
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01201096
First received: September 13, 2010
Last updated: September 22, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Liver Metastasis Neuroendocrine Tumors |
Radiation: 177Lutetium Procedure: Liver transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
Lutetium
U.S. FDA Resources
Further study details as provided by University of Jena:
Primary Outcome Measures:
- tumor free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2018 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| peptide radioreceptor therapy and liver transplantation |
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
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201096
Contacts
| 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 |
Locations
| Germany | |
| Center for neuroendokrine tumors, Zentralklinik Bad Berka | Recruiting |
| Bad Berka, Thüringen, Germany, 99437 | |
| Contact: Dieter Hörsch, PD Dr. med. 004936458 ext 52601 dieter.hoersch@zentralklinik.bad-berka.de | |
| Contact: R. P. Baum, Prof.Dr.med. 004936458 ext 53515 r.baum.pet@zentralklinik-bad-berka.de | |
| Principal Investigator: Dieter Hoersch, Prof. Dr. med | |
| Department of general-, visceral- and vascular surgery, University of Jena | Recruiting |
| Jena, Thüringen, Germany, 07743 | |
| 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 | |
| Principal Investigator: Christine Wurst, Dr.med. | |
Sponsors and Collaborators
University of Jena
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. med. Christine Wurst, Department of General-, Visceral- and Vascularsurgery, University of Jena |
| ClinicalTrials.gov Identifier: | NCT01201096 History of Changes |
| Other Study ID Numbers: | NEO-LEBE |
| Study First Received: | September 13, 2010 |
| Last Updated: | September 22, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Jena:
|
neuroendocrine tumor liver metastasis peptide receptor therapy gastro-entero-pancreatic system |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Neuroendocrine Tumors Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 16, 2013