Overview
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Description
This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).
Eligibility
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
- WBC410^9/ l, platelet 10010^9/ l and hemoglobin 90g/l
- With normal liver function test (TBILALTAST 2.5uln)
- With normal renal function test (creatinine 1.5uln or ccr 60ml/min)
- Satisfactory performance status: KARNOFSKY scale (KPS) > 70
- Patients must give signed informed consent
Exclusion Criteria:
- 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
- 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