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Best Therapy for Patients With Neuroendocrine Tumors

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Treatment Active 18 to 90 Other ZBB-NET-1
NCT00815620

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Zentralklinik Bad Berka

Dieter Hörsch, MD

Principal Investigator

Dieter Hörsch, MD		Ph: 0049-36458 Ext.52600
		Email: gast@zentralklinik-bad-berka.de

Richard P Baum, MD		Ph: 0049-36458 Ext.52200
		Email: info@rpbaum.de

Trial Sites

Germany

Bad Berka

Zentralklinik Bad Berka

Dieter Hörsch, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00815620
Information obtained from ClinicalTrials.gov on December 30, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.