Best Therapy for Patients With Neuroendocrine Tumors

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00815620

Acronym

BESTTHERAPYNET

Enrollment

150

Registered

2008-12-30

Start date

2008-11-30

Completion date

2017-03-31

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

neuroendocrine tumors, transcatheter arterial chemoembolization, selective internal radiotherapy, surgery, radio-frequency ablation, peptide-receptor radiotherapy, progression-free survival, quality of life, overall survival, weight, time of hospitalization

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
progression-free survival	2 years

Secondary

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

Countries

Germany

Outcome results