This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
474
Level Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c).
Fujian Cancer hospital
Fuzhou, Fujian, China
Regional failure-free survival
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
Time frame: 3 years
overall survival
time from the date of the start of chemotherapy to death due to any cause
Time frame: 3 years
Distant metastasis-free survival
The distant metastasis-free survival rate will be estimated using Kaplan-Meier
Time frame: 3 years
Local failure-free survival
until documented treatment local failure or death from any cause.
Time frame: 3 years
Patient's quality-of-life
European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire
Time frame: 3 years
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