A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)
• Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
• Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
• Aged between 18-70 years.
• Karnofsky scale (KPS)≥70.
• Normal bone marrow function.
• Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
• EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
• Normal liver and kidney function:
‣ total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
⁃ creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
• Given written informed consent.