Efficacy and safety of adjuvant peptide receptor radionuclide therapy after curative surgery of locoregional limited small intestine neuroendocrine neoplasia (APSIN) – A multi-centre, prospective, randomised, controlled, phase III study

#4413

Introduction: Our multi-centre, prospective, open-label, two-arm parallel group, randomised, controlled, phase III study will address the efficacy and safety of adjuvant peptide receptor radionuclide therapy after curative surgery of locoregional limited small intestine neuroendocrine neoplasia.

Aim(s): Primary objective is to evaluate the efficacy of adjuvant peptide receptor radionuclide therapy (PRRT) compared to standard care (close surveillance) in terms of relapse-free survival in locoregional limited small intestine neuroendocrine neoplasia (SI-NEN).

Materials and methods: We will include about 166 patients with locoregional limited small intestine neuroendocrine neoplasia after curative surgery. Patients will be randomised in a 1:1 ratio to either no PRRT or adjuvant PRRT. PRRT will include two cycles of injection of LUTATHERA® 7.4 GBq/200 mCi within 8 weeks + 1 week. Follow-up will be performed for 60 months.

Conference:

Presenting Author: Eilsberger F

Authors: Eilsberger F, Luster M, Rau J, Avci H, Schade-Brittinger C,

Keywords: adjuvant therapy, neuroendocrine neoplasia, small intestine, peptide receptor radionuclide therapy, PRRT,