This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of modified IMRT, of which CTV delineation was only based on geometric expansion from GTV.
All enrolled patients underwent intensity-modulated radiation therapy (IMRT). The IMRT technique was selected based on the equipment available at each treatment center and the patients' preferences, including IMRT, VMAT, or TOMOTHERAPY. According to our study design, all enrolled patients will be randomly assigned in a 1:1 ratio before radiation therapy. The target area definitions are based on the international ICRU reports No. 50 and No. 60. The specific target area definitions and prescribed doses for the two groups are as follows: 1. GTVp (70Gy/33Fx) Experimental Group: Gross tumor as seen on imaging and nasopharyngoscopy; Control Group: Gross tumor as seen on imaging and nasopharyngoscopy. 2. CTVp1 (60Gy/33Fx) Experimental Group: None; Control Group: GTVp + 5 mm + entire nasopharyngeal mucosa. 3. CTVp2 (54Gy/33Fx) Experimental Group: GTVp + 10 mm + entire nasopharyngeal mucosa; Control Group: GTVp + 10 mm + high-risk anatomical structures. 4. GTVn Experimental Group: Lymph nodes as seen on imaging; Control Group: Lymph nodes as seen on imaging. 5. CTVn Experimental Group: Defined according to CACA/CMDA guidelines; Control Group: Defined according to CACA/CMDA guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
474
CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.
Fujian Cancer hospital
Fuzhou, Fujian, China
RECRUITINGLocal failure-free survival (LFFS)
The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
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
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
Distant metastasis-free survival
The distant metastasis-free survival rate will be estimated using Kaplan-Meier
Time frame: 3 years
Patient's quality-of-life
uropean Organization for Research and Treatment of Cancer Quality-of-Life Head
Time frame: 3 years
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