The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
562
Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m\^2 every 3 weeks for 3 cycles.
Xingchen Peng
Chengdu, Sichuan, China
Disease-free survival
Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
Time frame: 3-year
Overall survival
Overall survival is calculated from randomization to death from any cause.
Time frame: 3-year
Locoregional recurrence-free survival
Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence.
Time frame: 3-year
Distant metastasis-free survival
Distant metastasis-free survival is calculated from randomization to the first remote metastases.
Time frame: 3-year
Objective response rates after treatments
Time frame: At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy
Number of participants with adverse events
Incidence of acute toxicity
Time frame: Every week during treatment, up to 4 weeks after treatment.
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