LiverNEO-LEBENCT01201096
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)
An observational study of Liver and Metastasis, run by University of Jena at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver, Metastasis, Neuroendocrine Tumors
- What is being tested?
- 177Lutetium and Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2010to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients with liver metastasis of neuroendocrine tumors of the small bowel, colon, pancreas or stomach. Primary tumor removed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Center for neuroendokrine tumors, Zentralklinik Bad Berka
Bad Berka, Thuringia, 99437
Dieter Hörsch, PD Dr. med., 004936458 ext. 52601, dieter.hoersch@zentralklinik.bad-berka.de
R. P. Baum, Prof.Dr.med., 004936458 ext. 53515, r.baum.pet@zentralklinik-bad-berka.de
- Recruiting
Department of general-, visceral- and vascular surgery, University of Jena
Jena, Thuringia, 07743
Christine Wurst, Dr.med., 00493641 ext. 9322450, christine.wurst@med.uni-jena.de
Utz Settmacher, Prof.Dr. med, 00493641 ext. 9322601, AVG@med.uni-jena.de
About this study
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
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.
Read the 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.
- Conditions
- Liver, Metastasis, Neuroendocrine Tumors
- Being tested
- 177Lutetium, Liver transplantation
- Keywords
- neuroendocrine tumor, liver metastasis, peptide receptor therapy, gastro-entero-pancreatic system
- Medical subject headings
- Neoplasm Metastasis, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177LutetiumRadiation
two cycles of 177Lutetium radioreceptor therapy within two month
Liver transplantationProcedure or surgery
about 9 month after finishing the receptor therapy liver transplantation takes place
| Study group | Role | What they receive |
|---|---|---|
| peptide radioreceptor therapy and liver transplantation | Not described Receives: Radiation: 177Lutetium; Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor free survival
Measured: 5 years
Secondary outcomes (1)
quality of life
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2015 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Investigators
- Christine Wurst, Dr. med., Principal investigator, Department of general-, visceral- and vascular surgery, University of JenaDieter Hörsch, Prof. Dr. med, Study director, Zentrum für neuroendokrine Tumore, Zentralklinik Bad BerkaUtz Settmacher, Prof. Dr. med., Study chair, Department of general-, visceral- and vascular surgery, University of JenaR. B. Baum, Prof.Dr.med., Principal investigator, Center of neuroendocrine tumors, Zentralklinik Bad Berka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201096
- Sponsor's protocol ID
- NEO-LEBE
- Acronym
- NEO-LEBE
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01201096
- Acronym / sponsor ID
- NEO-LEBE / NEO-LEBE
- Conditions
- Liver, Metastasis, Neuroendocrine Tumors
- Keywords
- neuroendocrine tumor, liver metastasis, peptide receptor therapy, gastro-entero-pancreatic system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peptide radioreceptor therapy and liver transplantation | – | Radiation: 177Lutetium, Procedure: Liver transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients with liver metastasis of neuroendocrine tumors of the small bowel, colon, pancreas or stomach. Primary tumor removed.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- prognostic relevant second tumor disease
- pregnancy
- undifferentiated neuroendocrine carcinoma (WHO II, G3)
- renal insufficiency > second degree
- progressive carcinoid conditioned heart disease (>NYHA II)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lutetiumtwo cycles of 177Lutetium radioreceptor therapy within two month | Radiation | peptide radioreceptor therapy and liver transplantation |
| Liver transplantationabout 9 month after finishing the receptor therapy liver transplantation takes place | Procedure or surgery | peptide radioreceptor therapy and liver transplantation |
Primary outcome
tumor free survival
Time frame: 5 years
1 secondary outcome
quality of life
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Wurst, Dr. med. principal investigator
Department of general-, visceral- and vascular surgery, University of Jena
Dieter Hörsch, Prof. Dr. med study director
Zentrum für neuroendokrine Tumore, Zentralklinik Bad Berka
Utz Settmacher, Prof. Dr. med. study chair
Department of general-, visceral- and vascular surgery, University of Jena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver and Metastasis, run by University of Jena at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Wurst, Dr. med. (00493641 ext. 9322450, christine.wurst@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2010.