Best Therapy for Patients With Neuroendocrine Tumors (BESTTHERAPYNET)

Zentralklinik Bad Berka

Status: Completed

Conditions: Neuroendocrine Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT00815620

ZBB-NET-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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 design

150 participants in 3 patient groups

1

Description:

patients undergoing local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy

2

Description:

patients undergoing surgery or radiofrequency ablation

3

Description:

patients undergoing peptide receptor radiotherapy