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Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)

This study has been completed.
Information provided by (Responsible Party):
Dieter Hoersch MD, Zentralklinik Bad Berka Identifier:
First received: December 29, 2008
Last updated: March 20, 2017
Last verified: March 2017
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.

Neuroendocrine Tumors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Best Therapy for Patients With Neuroendocrine Tumors

Resource links provided by NLM:

Further study details as provided by Zentralklinik Bad Berka:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index [ Time Frame: 2 years ]

Enrollment: 150
Study Start Date: November 2008
Study Completion Date: March 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy
patients undergoing surgery or radiofrequency ablation
patients undergoing 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


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with neuroendocrine tumors in a tertiary referal center

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00815620

Zentralklinik Bad Berka
Bad Berka, Germany, 99437
Sponsors and Collaborators
Zentralklinik Bad Berka
Principal Investigator: Dieter Hörsch, MD Zentralklinik Bad Berka GmbH
  More Information

Responsible Party: Dieter Hoersch MD, Senior consultant, Zentralklinik Bad Berka Identifier: NCT00815620     History of Changes
Other Study ID Numbers: ZBB-NET-1
Study First Received: December 29, 2008
Last Updated: March 20, 2017

Keywords provided by Zentralklinik Bad Berka:
neuroendocrine tumors
transcatheter arterial chemoembolization
selective internal radiotherapy
radio-frequency ablation
peptide-receptor radiotherapy
progression-free survival
quality of life
overall survival
time of hospitalization

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial processed this record on April 28, 2017