A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera® in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH).

ABSTRACT:

Background

Although neuroendocrine tumors (NET) are classed as rare, they have a high prevalence and their incidence is increasing. Effective treatment with lutetium ¹⁷-[177Lu]Lu-oxodotreotide (Lutathera®) is possible in patients with well-differentiated NET, improving progression-free survival (PFS), overall survival (OS), and quality of life (QoL). However, progression does occur. Retreatment with additional Lutathera® cycles is an option to extend PFS and OS. Two retreatment cycles are usually proposed. We aim to compare four versus two Lutathera® retreatment cycles in patients with new progression of a well-differentiated intestinal NET.

Methods

This will be a multicenter, randomized, controlled, open-label, phase II study in France (ReLUTH). The aim is to eva

SUBMITTER: Deshayes E 

PROVIDER: S-EPMC9773621 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature