Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2008-11-30
2017-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy
No interventions assigned to this group
2
patients undergoing surgery or radiofrequency ablation
No interventions assigned to this group
3
patients undergoing peptide receptor radiotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* secondary tumor
* advanced carcinoid heart disease requiring surgery
18 Years
90 Years
ALL
No
Sponsors
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Zentralklinik Bad Berka
OTHER
Responsible Party
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Dieter Hoersch MD
Senior consultant
Principal Investigators
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Dieter Hörsch, MD
Role: PRINCIPAL_INVESTIGATOR
Zentralklinik Bad Berka GmbH
Locations
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Zentralklinik Bad Berka
Bad Berka, , Germany
Countries
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Other Identifiers
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ZBB-NET-1
Identifier Type: -
Identifier Source: org_study_id
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