Induction chemotherapy followed by radiation for advanced nasopharyngeal carcinoma
Official title: 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
Run by Guilin Medical University, China · NCT05527470 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 440 (estimated) |
| Sponsor | Guilin Medical University, China Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Guilin, Guangxi and 1 other locations) |
| Status | Recruiting |
| Started | November 11, 2022 |
| Main results expected | November 11, 2025 |
| Study ends | November 11, 2027 |
| Registry record updated | May 3, 2023 |
| Trial ID | NCT05527470 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma at stage III-IVb.
✕Probably not a fit
Patients with uncontrolled life-threatening illnesses or those who have previously undergone chemotherapy or radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar induction chemotherapy approaches, but this specific combination with IMRT is being evaluated for the first time.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Docetaxel and SX-682 in head and neck cancers and prostate cancer
This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.
-
Becotatug Vedotin for EGFR-positive relapsed, refractory, or metastatic pediatric solid tumors
This trial will test Becotatug Vedotin, an EGFR-targeted antibody-drug conjugate, to see if it is safe and helps children aged 2–18 with EGFR-positive relapsed, refractory, or metastatic solid tumors.
-
Induction and maintenance with MRG003, Tislelizumab, and Capecitabine for locally recurrent nasopharyngeal cancer
This study tests a treatment combo of MRG003 and a PD-1 blocker first, then continues with Capecitabine plus the PD-1 blocker to see if it helps patients with locally recurrent NPC.
-
Lower-dose (40.2 Gy) versus standard-dose (49.2 Gy) radiotherapy to low‑risk areas for chemosensitive Stage II nasopharyngeal cancer
This trial will try a lower radiotherapy dose (40.2 Gy) instead of the standard 49.2 Gy for people with stage II nasopharyngeal cancer who had a strong response to induction chemo and have undetectable EBV DNA.
-
Screening for early nasopharyngeal (nose) cancer
This project tests whether blood and saliva markers can find nasopharyngeal cancer early in adults aged 35 to 60 who are at higher risk because of ethnicity or family history.
-
Proton versus photon radiation for nasopharyngeal cancer
This trial will test whether proton radiation works at least as well as standard photon radiation for adults newly diagnosed with nasopharyngeal cancer that has not spread.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.