To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
No evidence of distant metastasis (M0)
Age between 18-65
Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)
Age >65 or < 18 years
Treatment with palliative intent
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
Parallel
Docetaxel, nedaplatin, fluorouracil
DrugInduction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Docetaxel, cisplatin, fluorouracil
DrugInduction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Nedaplatin
DrugConcurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Cisplatin
DrugConcurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapy
RadiationIntensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 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.
Progress-Free Survival (PFS)
Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
Overall Survival(OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Locoregional Relapse-Free Survival(LRRFS)
Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause.
Distant metastasis-Free Survival(DMFS)
Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause.
Quality of life (QoL)
Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H\&N35). The EORTC QLQ-H\&N35 scale employs a 4-point response format ("not at all" to "very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits.
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