Neuroendocrine TumorsBESTTHERAPYNETNCT00815620
Best Therapy for Patients With Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors, run by Zentralklinik Bad Berka at 1 site in Germany.
Trial summary
A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Mar 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with neuroendocrine tumors in a tertiary referal center
Who may be able to join
- Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)
- Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy
- curative intent of all therapies possible
Who cannot join
- Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
- secondary tumor
- advanced carcinoid heart disease requiring surgery
Trial locations and contacts
1 site in 1 country.
About this study
A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.
Read the detailed description
Study design:
Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumors, transcatheter arterial chemoembolization, selective internal radiotherapy, surgery, radio-frequency ablation, peptide-receptor radiotherapy, progression-free survival, quality of life, overall survival, weight, time of hospitalization
- Medical subject headings
- Neuroendocrine Tumors, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy | |
| 2 | patients undergoing surgery or radiofrequency ablation | |
| 3 | patients undergoing peptide receptor radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 2 years
Secondary outcomes (1)
overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentralklinik Bad Berka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Hoersch MD, Zentralklinik Bad Berka
- Investigators
- Dieter Hörsch, MD, Principal investigator, Zentralklinik Bad Berka GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815620
- Sponsor's protocol ID
- ZBB-NET-1
- Acronym
- BESTTHERAPYNET
- Status last verified
- Mar 2017
- First submitted
- 29 Dec 2008
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Therapy for Patients With Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00815620
- Acronym / sponsor ID
- BESTTHERAPYNET / ZBB-NET-1
- Conditions
- Neuroendocrine Tumors
- Keywords
- neuroendocrine tumors, transcatheter arterial chemoembolization, selective internal radiotherapy, surgery, radio-frequency ablation, peptide-receptor radiotherapy, progression-free survival, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zentralklinik Bad BerkaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Dec 2008 (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.
A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.
Detailed description
Study design:
Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy |
| 2 | – | –patients undergoing surgery or radiofrequency ablation |
| 3 | – | –patients undergoing peptide receptor radiotherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with neuroendocrine tumors in a tertiary referal center
Key inclusion criteria (3 listed)
- Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)
- Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy
- curative intent of all therapies possible
Key exclusion criteria (3 listed)
- Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
- secondary tumor
- advanced carcinoid heart disease requiring surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression-free survival
Time frame: 2 years
1 secondary outcome
overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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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.
Dieter Hörsch, MD principal investigator
Zentralklinik Bad Berka GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Zentralklinik Bad Berka at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2 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 21 Mar 2017.