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Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00815620
Recruitment Status : Completed
First Posted : December 30, 2008
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Neuroendocrine Tumors

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


Study Design

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Best Therapy for Patients With Neuroendocrine Tumors
Study Start Date : November 2008
Primary Completion Date : August 2016
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 30, 2008    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 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
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue