Overview

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