[Translation] A phase III (pivotal phase) study evaluating investigator's choice of radiation therapy alone or in combination with cetuximab to activate NBTXR3 in elderly patients with locally advanced squamous cell carcinoma of the head and neck who are ineligible for platinum-based chemotherapy
主要目的:评价研究者选择的单独放疗(RT)或联合西妥昔单抗的放疗激活瘤内注射NBTXR3在受试者中的生存结局(以下简称NBTXR3/RT±西妥昔单抗与RT±西妥昔单抗)。
次要目的:关键次要目的是评价NBTXR3/RT±西妥昔单抗与RT±西妥昔单抗的长期生存结局。
[Translation] Primary objective: To evaluate the survival outcomes of subjects receiving radiotherapy (RT) alone or in combination with cetuximab (hereinafter referred to as NBTXR3/RT±cetuximab vs. RT±cetuximab) in subjects selected by the investigator (hereinafter referred to as NBTXR3/RT±cetuximab vs. RT±cetuximab).
Secondary objective: The key secondary objective is to evaluate the long-term survival outcomes of NBTXR3/RT±cetuximab vs. RT±cetuximab.