To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy
To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
452
Patients in experimental group received reduced dose IMRT
cisplatin-based induction chemotherapy for two cycles
cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)
Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong, China
PFS (progression-free survival)
Defined as the time from randomization to documented disease recurrence (either distant metastasis or locoregional disease recurrence) or death from any cause, whichever occurred first.
Time frame: 2 year
Overall Survival(OS)
Defined as the time from randomization to death from any cause
Time frame: 2 year
Locoregional relapse-free survival(LRFS)
Defined as the time from randomization to the first local or regional recurrence, or death from any cause. follow-up visit.
Time frame: 2 year
Distant metastasis-free survival(DMFS)
Defined as the time from randomization to the first distant metastasis or death from any cause.
Time frame: 2 year
Overall response rate
Tumour response rate was classified according to RECIST, version 1.1
Time frame: 3 months
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Time frame: 2 year
Change of QoL
QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy
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Time frame: 1 year
Change of EORTC quality of life questionnaire(QLQ) Head and Neck score
QoL scores were assessed by using EORTC quality of life questionnaire(QLQ) Head and Neck. The QLQ-H\&N35 is composed of seven multi-item symptom scales (pain, swallowing, sensation, speech, eating from a social,perspective, social interactions, and sexuality) and 11 single-item symptom scales (teeth, opening mouth,dry mouth, sticky saliva,coughing, felt ill, pain medication use, nutritional supplementation, feeding tube requirement, weight loss, and weight gain). All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.All of the scores mentioned above were assessed at the below time point:before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy
Time frame: 1 year