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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 346 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 1, 2020 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 23, 2019 |
| Trial ID | NCT04136886 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
- Study coordinator: Fei Han, doctor
- Email: hanfei@sysucc.org.cn
- Phone: 8620-87343030
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.