Comparing two treatment approaches for advanced nasopharyngeal cancer
Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
This study is testing two different treatment plans for advanced nasopharyngeal cancer to see if one works just as well as the other for patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 447 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05062005 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the effectiveness of concurrent chemoradiotherapy compared to a combination of induction chemotherapy followed by concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma. The study aims to determine if the concurrent approach is not inferior to the combined treatment in terms of patient outcomes. Participants will receive either treatment regimen and will be monitored for efficacy and safety. The trial is multi-center, allowing for a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with pathologically confirmed non-keratinizing nasopharyngeal carcinoma at stage T3-4N0-1 without distant metastasis.
Not a fit: Patients seeking palliative treatment or those with other concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more effective treatment option for patients with locally advanced nasopharyngeal carcinoma.
How similar studies have performed: Other studies have explored similar treatment approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-65 years old; 2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 3. Stage T3-4N0-1 (according to the UICC/AJCC 8th); 4. No distant metastasis; 5. Have not received anti-cancer treatment in the past; 6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1; 7. Adequate hematologic, hepatic and renal function. Exclusion Criteria: 1. The purpose of treatment is palliative; 2. Diagnosed with other malignant tumors at the same time; 3. Malignant tumor history; 4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period; 5. Combined serious illness.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shuang Wu, PHD
- Email: wush77@mail.sysu.edu.cn
- Phone: +862087755766
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.