Overview

Personalized CAPTEM Radiopeptide Therapy of Advanced, Non-resectable Neuroendocrine Cancer

Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
This is a non-randomized, phase II, open label study. The purpose of this study is to estimate Progression Free Survival (PFS) after treatment with Peptide Receptor Radionuclide Therapy (PRRT) 177Lu-DOTATOC standard dose (up to 4x7,4GBq 177Lu DOTATOC) in combination with capecitabine (CAP) and temozolomide (TEM) - CAPTEM. Patients with advanced, non-resectable and/or progressive gastro-entero-pancreatic neuroendocrine tumors, GEP-NET, (G1, G2), in selected cases with high proliferation index (Ki-67> 20%, usually below 55%), NETG3, with overexpression of somatostatin receptor (SSTR positive) will be enrolled in the study.
Phase:
Phase 2
Details
Lead Sponsor:
University of Warmia and Mazury
Collaborators:
Maria Sklodowska-Curie Institute - Oncology Center
Medical University of Warsaw
National Center for Research and Development, Poland
The Diagnostic and Therapeutic Center Gammed; Poland
The Medical University of Warsaw; Poland
Treatments:
Capecitabine
Edotreotide
Octreotide
Temozolomide