Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 to 65

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.

More Nasopharyngeal Carcinoma trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment440 (estimated)
SponsorGuilin Medical University, China
Academic / other
Drugs / interventionschemotherapy, radiation
Locations2 sites (Guilin, Guangxi and 1 other locations)
StatusRecruiting
StartedNovember 11, 2022
Main results expectedNovember 11, 2025
Study endsNovember 11, 2027
Registry record updatedMay 3, 2023
Trial IDNCT05527470 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.