Best Therapy for Patients With Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

— BESTTHERAPYNET  

Official title:

Best Therapy for Patients With Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815620
• Other study ID #: ZBB-NET-1
• Status: Completed
• Phase: N/A
• First received: December 29, 2008
• Last updated: March 20, 2017
• Start date: November 2008
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Zentralklinik Bad Berka
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka

Sponsors (1)

Lead Sponsor	Collaborator
Zentralklinik Bad Berka

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		2 years
Secondary	overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index		2 years