Nedaplatin in Treatment for Nasopharyngeal Carcinoma

Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.

To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).

Inclusion Criteria:

• 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
• WBC≥4×10^9/ l, platelet ≥ 100×10^9/ l and hemoglobin ≥ 90g/l
• With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
• With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
• Satisfactory performance status: KARNOFSKY scale (KPS) > 70
• Patients must give signed informed consent

Exclusion Criteria:

• Treatment with palliative intent
• The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
• History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
• History of previous radiotherapy
• Pregnancy or lactation
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance.