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Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dieter Hoersch MD, Zentralklinik Bad Berka
ClinicalTrials.gov Identifier:
NCT00815620
First received: December 29, 2008
Last updated: March 20, 2017
Last verified: March 2017
  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: 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 Dieter Hoersch MD, 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)
Groups/Cohorts
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

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

  Eligibility

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815620

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

Responsible Party: Dieter Hoersch MD, Senior consultant, Zentralklinik Bad Berka
ClinicalTrials.gov 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 Dieter Hoersch MD, Zentralklinik Bad Berka:
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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 25, 2017