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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):
Dieter Hoersch MD, Zentralklinik Bad Berka

Tracking Information
First Submitted Date December 29, 2008
First Posted Date December 30, 2008
Last Update Posted Date March 21, 2017
Study Start Date November 2008
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2008)
progression-free survival [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00815620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 29, 2008)
overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Best Therapy for Patients With Neuroendocrine Tumors
Official Title Best Therapy for Patients With Neuroendocrine Tumors
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with neuroendocrine tumors in a tertiary referal center
Condition Neuroendocrine Tumors
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 20, 2017)
150
Original Estimated Enrollment
 (submitted: December 29, 2008)
5
Actual Study Completion Date March 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00815620
Other Study ID Numbers ZBB-NET-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dieter Hoersch MD, Zentralklinik Bad Berka
Study Sponsor Zentralklinik Bad Berka
Collaborators Not Provided
Investigators
Principal Investigator: Dieter Hörsch, MD Zentralklinik Bad Berka GmbH
PRS Account Zentralklinik Bad Berka
Verification Date March 2017