This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy(IMRT)group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy
Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGcomplete response (CR) rate
3 months after treatment
Time frame: 3 months
Acute toxicities
Acute toxicity will be measured by CTCAE3.0
Time frame: 2 years
Overall Survival
1 years,3 years and 5 years overall survival,disease free survival,distant metastases free survival
Time frame: 1,3,5 years
cost-effectiveness ratio
Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).
Time frame: 3 months
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