Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

NCT04437329 · tracked via the Priya Life Science China tracker

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Phase

Phase 3

Started

2020-08-01

Last updated

2022-05-10

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Docetaxel, nedaplatin, fluorouracilDocetaxel, cisplatin, fluorouracilNedaplatin →Cisplatin →Intensity modulated-radiotherapy

Docetaxel, nedaplatin, fluorouracil: Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

Docetaxel, cisplatin, fluorouracil: Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

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

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

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Official registry record

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.

View NCT04437329 on ClinicalTrials.gov ↗ ← All trials in China