Table 3.

NANORAY-312 study objectives and endpoints of NBTXR3/RT ± cetuximab versus RT ± cetuximab.

Primary objective	Primary endpoint
To evaluate survival outcomes (PFS)	PFS: time from randomization to locoregional recurrence, locoregional progression, distant progression, or death from any cause, whichever occurs first
Key secondary objective	Key secondary endpoint
To evaluate long-term survival (OS)	OS defined as time from randomization to death from any cause
Other secondary objective	Other secondary endpoint
To evaluate locoregional control	Time to locoregional progression: time from randomization to locoregional progression or death, whichever occurs first
To evaluate distant control	Time to distant progression: time from randomization to distant progression or death whichever occurs first
To evaluate H&N cancer specific event-free survival outcomes	H&N cancer-specific event-free survival: time from randomization to locoregional recurrence, locoregional progression, distant progression, or H&N cancer-related death, as per RECIST 1.1, whichever occurs first
To evaluate long-term H&N cancer-specific survival outcomes	H&N cancer-specific survival: time from randomization to H&N cancer-related death
To evaluate safety and tolerability	AEs, safety laboratory parameters, vital signs, ECOG PS, and physical examinations
To assess PROs including symptoms, function, and HRQoL	Change from baseline over time in symptoms, function, and HRQoL using the EORTC QLQ-H&N35 and the EQ-5D-5 L instrument
To evaluate the tumor response	ORR (as defined by RECIST 1.1): rate of CR + PR DoR (as defined by RECIST 1.1): time from CR or PR to progression of disease, unequivocal clinical progression, or death, whichever occurs first

AEs, adverse events; CR, complete response; DoR, duration of response; ECOG, Eastern Cooperative Oncology Group; EORTC, European Organization for Research and Treatment of Cancer; EQ-5D-5 L, 5-level EuroQol 5-dimension; GY, gray; H&N, head and neck; HRQoL, health-related quality of life; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PRO, patient-reported outcome; PR, partial response; PS, performance status; QLQ-H&N35, Quality of Life Questionnaire – Head and Neck Cancer Module; RECIST, Response Evaluation Criteria In Solid Tumors; RT, radiotherapy.