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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
474
Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
Standard delineation
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
RECRUITINGRegional 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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
Global Health Status
The quality of life of patients in the two groups will be assessed using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30).
Time frame: 1year, 2 year and 3 years
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