Comparing nedaplatin and cisplatin for treating nasopharyngeal carcinoma
Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma：a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study
This study is testing whether a new chemotherapy drug called nedaplatin is as effective and safe as the standard drug cisplatin for treating advanced nasopharyngeal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Affiliated Cancer Hospital & Institute of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04437329 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with newly diagnosed non-keratinizing nasopharyngeal carcinoma at stages III-IVa without distant metastasis.
Not a fit: Patients with keratinizing nasopharyngeal carcinoma or those over 65 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective treatment option for patients with nasopharyngeal carcinoma.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of nedaplatin and cisplatin is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.