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Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Zentralklinik Bad Berka
Sponsor:
Information provided by (Responsible Party):
Dieter Hoersch MD, Zentralklinik Bad Berka
ClinicalTrials.gov Identifier:
NCT00815620
First received: December 29, 2008
Last updated: January 4, 2016
Last verified: January 2016

December 29, 2008
January 4, 2016
November 2008
September 2016   (final data collection date for primary outcome measure)
progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00815620 on ClinicalTrials.gov Archive Site
overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
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Best Therapy for Patients With Neuroendocrine Tumors
Best Therapy for Patients With Neuroendocrine Tumors
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients with neuroendocrine tumors in a tertiary referal center
Neuroendocrine Tumors
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  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
September 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
  • secondary tumor
  • advanced carcinoid heart disease requiring surgery
Both
18 Years to 90 Years   (Adult, Senior)
No
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
 
NCT00815620
ZBB-NET-1
No
Not Provided
Not Provided
Dieter Hoersch MD, Zentralklinik Bad Berka
Zentralklinik Bad Berka
Not Provided
Principal Investigator: Dieter Hörsch, MD Zentralklinik Bad Berka GmbH
Zentralklinik Bad Berka
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP