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| Sponsored by: |
Zentralklinik Bad Berka |
|---|---|
| Information provided by: | Zentralklinik Bad Berka |
| ClinicalTrials.gov Identifier: | NCT00815620 |
Purpose
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.
| Condition |
|---|
|
Neuroendocrine Tumors |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Best Therapy for Patients With Neuroendocrine Tumors |
| Estimated Enrollment: | 5 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy
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2
patients undergoing surgery or radiofrequency ablation
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3
patients undergoing peptide receptor radiotherapy
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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
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with neuroendocrine tumors in a tertiary referal center
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dieter Hörsch, MD | 0049-36458 ext 52600 | gast@zentralklinik-bad-berka.de |
| Contact: Richard P Baum, MD | 0049-36458 ext 52200 | info@rpbaum.de |
| Germany | |
| Zentralklinik Bad Berka | Recruiting |
| Bad Berka, Germany, 99437 | |
| Principal Investigator: Dieter Hörsch, MD | |
| Principal Investigator: | Dieter Hörsch, MD | Zentralklinik Bad Berka GmbH |
More Information
| Responsible Party: | Zentralklinik Bad Berka GmbH, Bad Berka, Germany ( Dieter Hoersch MD ) |
| Study ID Numbers: | ZBB-NET-1 |
| Study First Received: | December 29, 2008 |
| Last Updated: | December 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00815620 |
| Health Authority: | Germany: Ministry of Health |
|
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 |
|
Body Weight Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Disease Progression |
Neuroepithelioma Quality of Life Neuroendocrine Tumors |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue |
