Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study
Who is this study for? Patients with locally advanced nasopharyngeal carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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)
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Jinquan Liu, M.D
609149209@qq.com
0086-137-1086-6485
Backup
Bin Qi, M.D
qibin020@126.com
0086-135-8058-0985
Time Frame
Start Date:2020-08-01
Estimated Completion Date:2029-06-30
Participants
Target number of participants:352
Treatments
Experimental: DNF-N
1. Induction chemotherapy:~ three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks~2. Concurrent chemoradiotherapy:~ three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy~3. Radiotherapy: radical intense modulated radiation therapy
Active_comparator: DPF-P
1. Induction chemotherapy:~ three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks~2. Concurrent chemoradiotherapy:~ three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy~3. Radiotherapy: radical intense modulated radiation therapy