START-NET: Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors – An open-label, multi-center, randomised phase III trial comparing safety and efficacy of personalised vs non-personalised radionuclide therapy with 177Lu-DOTATOC

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Introduction: Peptide receptor radionuclide therapy (PRRT) with fixed activity dosing is an established treatment for advanced neuroendocrine tumors (NETs). Emerging data suggest that patients may benefit from a personalized treatment approach. Aggressive NET is believed to benefit from more intensive treatment, one example being FDG-PET positive tumors have shown benefit from combining PPRT with chemotherapy. Dosimetry is another means of achieving personalisation and can be used to increase the tumor radiation doses without surpassing the toxicity limits of organs at risk.

Aim(s): The primary objective is to compare the efficacy of personalised vs non-personalised PRRT.

Materials and methods: START-NET is a multicentre randomized controlled trial for patients with somatostatin receptor positive, advanced and progressive NETs. Patients are randomly assigned to receive either non-personalised treatment with 4 cycles of PRRT (control), or personalised treatment where FDG negative patients receive dosimetry-based PRRT only, and FDG-PET positive patients receive capecitabine combined with dosimetry-based PRRT (experimental). The primary objective is to compare the efficacy of personalised vs non-personalised PRRT. The primary endpoint is progression-free survival.

Conference:

Presenting Author: Asp P

Authors: Asp P, Sjögreen-Gleisner K, Fröss-Baron K, Sandström M, Hallqvist A,

Keywords: NET, PRRT, dosimetry, PET, 177Lu-DOTATOC, capecitabine,