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Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Zentralklinik Bad Berka.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zentralklinik Bad Berka
ClinicalTrials.gov Identifier:
NCT00815620
First received: December 29, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Zentralklinik Bad Berka:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815620

Contacts
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

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

No publications provided

Responsible Party: Dieter Hoersch MD, Zentralklinik Bad Berka GmbH, Bad Berka, Germany
ClinicalTrials.gov Identifier: NCT00815620     History of Changes
Other Study ID Numbers: ZBB-NET-1
Study First Received: December 29, 2008
Last Updated: December 29, 2008
Health Authority: Germany: Ministry of Health

Keywords provided by 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
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 16, 2013