Comparing nedaplatin and cisplatin for treating nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial aims to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. The study involves a prospective, parallel, randomized, open-label design where participants will receive either a regimen of nedaplatin, docetaxel, and fluorouracil or a regimen of cisplatin, docetaxel, and fluorouracil, followed by radical intensity-modulated radiation therapy. The primary endpoint of the trial is progression-free survival (PFS), which will help determine the non-inferiority of nedaplatin compared to cisplatin.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jinquan Liu, M.D
• Email: 609149209@qq.com
• Phone: 0086-137-1086-6485

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.