Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 70

Concurrent chemotherapy with IMRT for recurrent nasopharyngeal carcinoma

Official title: Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)

Run by Sun Yat-sen University · NCT04136886 · Data updated 2026-11-12

This study is testing if adding chemotherapy with cisplatin to radiation therapy helps people with recurrent nasopharyngeal cancer do better and experience fewer side effects compared to just radiation alone.

More Nasopharyngeal Carcinoma trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment346 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedJanuary 1, 2020
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedOctober 23, 2019
Trial IDNCT04136886 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-70 with confirmed locally recurrent T3/T4 nasopharyngeal carcinoma who have not experienced distant metastasis.

Probably not a fit

Patients with only regional recurrence or evidence of distant metastasis will 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 phase III randomized controlled study aims to evaluate the effectiveness of concurrent chemotherapy using cisplatin combined with intensity-modulated radiotherapy (IMRT) in patients with locally recurrent T3/T4 nasopharyngeal carcinoma. The study compares this combination treatment to IMRT alone to determine if it improves local control of the cancer and reduces severe late toxicities. Eligible participants include those who have pathologically confirmed recurrent NPC and meet specific health criteria. The study is designed to provide insights into better treatment options for this challenging condition.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with recurrent nasopharyngeal carcinoma.

How similar studies have gone: Other studies have shown promising results with concurrent chemotherapy and radiotherapy approaches in similar cancer types, indicating potential for success in this study.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;

  2.No evidence of distant metastasis

  3.More than 1 year from the end of the first course of radiotherapy

  4.Male, or female not in the phase of lactating or pregnancy

  5.ECOG 0-2

  6.Aged 18-70 years old

  7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L

  8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits

  9.Written informed consort signed

Exclusion Criteria:

1. Only regionally recurrence
2. Evidence of distant metastasis
3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
4. Severe, active co-morbidity
5. Prior anti-tumor treatment after diagnosis of local recurrence
6. MRI was not performed 3 months after the first course of radiotherapy
7. Abnormal function of heart, brain and lungs, etc
8. Lactation or pregnancy
9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Where it's running

  • WangHanYu
    Guangzhou, Guangdong, 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.