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Recruiting Phase 3 NCT04437329

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

Trial Parameters

Condition Nasopharyngeal Carcinoma
Sponsor Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 352
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2020-08-01
Completion 2028-06-30
Interventions
Docetaxel, nedaplatin, fluorouracilDocetaxel, cisplatin, fluorouracilNedaplatin

Brief Summary

To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

Eligibility Criteria

Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III 2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system 3. No evidence of distant metastasis (M0) 4. Age between 18-65 5. WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l 6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln) 7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min) 8. Satisfactory performance status: KARNOFSKY scale (KPS) \> 70 9. Patients must give signed informed consent Exclusion Criteria: 1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I) 2. Age \>65 or \< 18 years 3. Treatment with palliative intent 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer 5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the

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