Comparing two chemotherapy regimens for advanced nasopharyngeal carcinoma
Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：: A Phase 3 Trial
This study is testing which chemotherapy treatment, cisplatin or carboplatin, works better for people with advanced nasopharyngeal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 482 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03919552 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of cisplatin-based versus carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Patients with non-keratinizing NPC staged T3-4NxM0/TxN2-3 will be randomly assigned to receive either treatment regimen. The primary endpoint is overall survival, while secondary endpoints include various survival rates and treatment response. The study will analyze efficacy in an intention-to-treat population and safety in those who receive their assigned treatment.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-65 with newly diagnosed non-keratinizing nasopharyngeal carcinoma at specific stages without distant metastasis.
Not a fit: Patients with keratinizing squamous cell carcinoma or those receiving palliative treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced nasopharyngeal carcinoma.
How similar studies have performed: Previous studies have shown varying success with chemoradiotherapy regimens for NPC, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). * Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) \> 70. * Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. * Adequate renal function: creatinine clearance ≥60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Age ≥65 years or \<18 years. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation. * History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Where this trial is running
Guangzhou, Guangdong
- Southern medical university — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jian Guan, Ph.D.
- Email: 51643930@qq.com
- Phone: +86-13632102247
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.