Endpoints
death
ADVERSE EVENTS, EVENT, EVENTS, SECONDARY, RESIDUAL DISEASE
The primary endpoint is time to treatment failure (TTF) 1 in all randomized patients. TTF1 is defined as time from randomization to the date of progression, or determination of residual disease after the completion of the protocol treatment, or death from any cause, whichever occurred first, and it is censored at the last day the patient is alive without any evidence of progression. The secondary endpoints are overall survival (OS), complete response rate, progression-free survival (PFS), locoregional relapse-free survival, TTF2, acute and late adverse events, quality of life (QOL) score, and swallowing function score. OS is defined as the time from randomization to death from any cause and is censored on the last contact day for a surviving patient. PFS is defined as the time from randomization to the earliest date of progression or death from any cause and is censored on the last contact day when the patient is alive without any evidence of relapse. In the definition of TTF2, clinical residual disease in TTF1 events is not regarded as an event or censor of TTF2, if complete resection is conducted by salvage surgery and subsequent histopathological examination reveals pathological complete response.