Phase III Trial Comparing Lutetium-177 PRRT Plus Chemotherapy Versus PRRT Alone in FDG-Positive Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors

What this Trial Is About

Neuroendocrine tumors (NETs) are a diverse group of tumors that range from slow-growing, well-differentiated types to more aggressive carcinomas. This trial focuses on well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that show FDG positivity, which indicates a more aggressive tumor behavior. The study aims to evaluate if combining Peptide Receptor Radionuclide Therapy (PRRT) with chemotherapy improves outcomes compared to PRRT alone, addressing a gap in treatment recommendations for intermediate to high-grade NETs. Participants will be randomly assigned to one of two treatment groups. One group will receive four cycles of PRRT using Lutetium-177 DOTATATE, which targets somatostatin receptors on tumor cells. The other group will receive the same PRRT combined with chemotherapy drugs capecitabine and temozolomide, which target more aggressive tumor cells. This open-label Phase 3 trial compares these approaches to better understand the benefits of adding chemotherapy to PRRT. Throughout the study, participants will be monitored for progression-free survival up to 36 months, with additional assessments of overall survival and quality of life for up to 24 months. Evaluations include imaging with Ga-68-DOTANOC PET/CT and FDG PET to assess tumor response and metabolic activity, along with clinical and biochemical tests. Researchers will track treatment effects, safety, and participant well-being during and after treatment to determine the impact of the combined therapy.

PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)