Nedaplatin: Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Cisplatin: Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
Intensity modulated-radiotherapy: Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
Study summary
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Progress-Free Survival (PFS) — 3 years Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
Trial sites (1)
Facility
City
Region
Status
Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Affiliated Cancer Hospital & Institute of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.