This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions.
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
Cadonilimab: 10mg/kg, Q3W, 3 cycles
Low-dose radiotherapy will be performed to study group, with the use of IMRT.
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Time frame: 3 years
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Time frame: 3 years
Local recurrence-free survival
From the date of randomization to local recurrence or any death
Time frame: 3 years
Regional recurrence-free survival
From the date of randomization to regional recurrence or any death
Time frame: 3 years
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Time frame: 3 years
Acute toxicities
Assessed with CTCAE v5.0
Time frame: From the start of treatment until 3 months post treatment
Late toxicities
Assessed with RTOG/EORTC
Time frame: 3 years post treatment
Quality of life score
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Time frame: Through study completion, an average of 3 years
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