CAPTEM and PRRT to improve overall response for pancreatic NETs (pNETs) – The CORONET trial

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Introduction: Patients with advanced pNETs have limited treatment options. The NETTER-2 and OCLURANDOM trials have established peptide receptor radionuclide therapy (PRRT) as a standard treatment in pNETs; CAPTEM chemotherapy is an active regimen in NENs. The CONTROL NETs trial has shown promising response rate and progression-free survival with PRRT+CAPTEM, warranting further investigation.

Aim(s): We propose a randomized phase III trial to investigate PRRT +- CAPTEM in advanced high-risk pNETs.

Materials and methods: CORONET is a phase III open label trial for patients with G2-3 pNETs with 0-1 lines of prior treatment. Patients will be randomized 1:1 to 4 cycles of PRRT (7.8GBq 177Lu-DOTA-octreotate) alone on day 10 every 8 weeks or PRRT with capecitabine (750mg/m2 b.i.d. days 1-14) and temozolomide (75mg/m2 b.i.d. days 10-14) every 8 weeks. Translational endpoints include PET radiomics, ctDNA analysis, and analysis of clonal heterogeneity of indeterminate potential (CHIP) for risk stratification of treatment-related MDS/AML. Health-related quality of life (QLQ-C30) and health economic analyses will also be performed.

Conference:

Presenting Author:

Authors: Chan D, Doherty M, Singh S, Michael M, Kong G,

Keywords: PRRT, CAPTEM, Randomized Trial, Phase III,