PReCedeNT trial: Phase III randomized-controlled trial of Lutetium - 177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) plus Chemotherapy versus PRRT alone in FDG-avid, Well-differentiated Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

ABSTRACT:

Background

Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the standard of care for well-differentiated metastatic or locally advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, tumor heterogeneity, particularly in FDG-avid tumors, can limit treatment effectiveness. The PReCedeNT trial aims to evaluate the efficacy of combining PRRT with capecitabine and temozolomide (CAPE-TEM) chemotherapy compared to PRRT alone in patients with FDG-avid, well-differentiated GEP-NETs.

Methods

This single-center, randomized, open-label, phase III trial will enroll patients with FDG-avid, well-differentiated GEP-NETs. Participants will be randomized in a 1:1 ratio to receive either PRRT alone or PRRT plus CAPE-TEM chemotherapy. The primary end

SUBMITTER: Puranik AD 

PROVIDER: S-EPMC12560366 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature