Induction chemotherapy followed by radiation for advanced nasopharyngeal carcinoma
A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
This study is testing if starting treatment with chemotherapy followed by radiation helps people with advanced nasopharyngeal cancer live longer and feel better compared to just radiation alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Guilin Medical University, China Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Guilin, Guangxi and 1 other locations) |
| Trial ID | NCT05527470 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of induction chemotherapy using gemcitabine and cisplatin, followed by intensity-modulated radiation therapy (IMRT) or concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Patients will be randomized into two groups: one receiving IMRT alone and the other receiving IMRT with concurrent cisplatin. The goal is to evaluate whether the addition of induction chemotherapy improves survival rates while minimizing acute toxicities. The study will focus on patients with stage III-IVA nasopharyngeal carcinoma, assessing treatment outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma at stage III-IVb.
Not a fit: Patients with uncontrolled life-threatening illnesses or those who have previously undergone chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and reduce treatment-related toxicities for patients with advanced nasopharyngeal carcinoma.
How similar studies have performed: Other studies have shown promising results with similar induction chemotherapy approaches, but this specific combination with IMRT is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); 2. Tumor staged as III-IVb (according to the 8th AJCC edition); 3. No pregnant female; 4. Age between 18-65; 5. Normal complete blood count level (hemoglobin \>10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL); 6. Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase \< 2.5 times higher than upper limit); 7. Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min); 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. Without radiotherapy or chemotherapy; 10. Patients must give signed informed consent. Exclusion Criteria: 1. Disease progression in the process of the treatment; 2. The presence of uncontrolled life-threatening illness; 3. History of previous radiotherapy or chemotherapy; 4. Pregnancy or lactation.
Where this trial is running
Guilin, Guangxi and 1 other locations
- Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (Recruiting)
- Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Recruiting)
Study contacts
- Study coordinator: Wei Jiang, PhD
- Email: weijiang@glmc.edu.cn
- Phone: +86-2882906
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.