This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.
None
History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
History of neck surgery;
Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5 × ULN), or psychiatric disorders;
Parallel
Modified delineation
RadiationModified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
Standard delineation
RadiationStandard delineation
Regional Recurrence-free Survival
Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date.
Overall Survival
Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death from any cause or the last follow-up date.
Disease-free Survival
Disease-Free Survival (DFS) is defined as the time interval from the date of randomization to the date of tumor recurrence or death from any cause.
Hypothyroidism-Free Survival
Hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of hypothyroidism or the last follow-up date.
Clinical Hypothyroidism-Free Survival
Clinical hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of clinical hypothyroidism or the last follow-up date.
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