A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
complete response (CR) rate
3 months after treatment
3 months
No
Wang R. sheng, M.D.
Study Chair
Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University
China: Ethics Committee
GuangxiMU
NCT01479504
November 2011
December 2017
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