Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2029-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Treatments: Cisplatin; Docetaxel; Fluorouracil; Nedaplatin

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 primary tumor or nodes

6. History of previous radiotherapy

7. Pregnancy or lactation

8. 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