Best Therapy for Patients With Neuroendocrine Tumors

Completed

• Conditions: Neuroendocrine Tumors

• Registration Number: NCT00815620
• Lead Sponsor: Zentralklinik Bad Berka

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Study First Posted: 2008-12-30
• Primary Completion: 2016-08
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival	2 years

Secondary Outcome Measures

Name	Time	Method
overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index	2 years

Trial Locations

Locations (1)

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany