- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815620
Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bad Berka, Germany, 99437
- Zentralklinik Bad Berka
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dieter Hörsch, MD, Zentralklinik Bad Berka GmbH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZBB-NET-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroendocrine Tumors
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Gastroenteropancreatic Neuroendocrine TumorChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdvanced Gastroenteropancreatic Neuroendocrine Tumor
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsRecruitingNeuroendocrine Tumors,GastroenteropancreaticTaiwan
-
Grupo Espanol de Tumores NeuroendocrinosActive, not recruitingNeuroendocrine Tumors | Neuroendocrine Neoplasm | Gastroenteropancreatic Neuroendocrine TumorSpain
-
Australasian Gastro-Intestinal Trials GroupCompletedMidgut Neuroendocrine Tumours | Pancreatic Neuroendocrine TumoursAustralia
-
Amr Mohamed MDNovatek PharmaceuticalsRecruitingNeuroendocrine Carcinoma | Gastroenteropancreatic Neuroendocrine Tumor | Gastroenteropancreatic Neuroendocrine Neoplasm | Mixed Neuroendocrine-Non Neuroendocrine NeoplasmUnited States
-
Francesco De CobelliCompleted
-
TaiRx, Inc.Active, not recruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Tumor | Lung Neuroendocrine NeoplasmTaiwan
-
Memorial Sloan Kettering Cancer CenterRecruitingNeuroendocrine Tumors | Liver-Dominant Metastatic Pancreatic Neuroendocrine TumorsUnited States
-
University Hospital, Basel, SwitzerlandSwiss National Science Foundation; Paul Scherrer Institute (PSI)RecruitingNeuroendocrine Neoplasia's (NENs) | Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)Switzerland