Clinical trial · Interventional
Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT
A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
NCT04215510CI-TRIAL-00050254not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endonasal endoscopic surgery | Procedure | — | UNRESOLVED |
| radiation therapy(IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- endonasal endoscopic surgery group
- description
- 143 participants in group 1 will undergo endoscopic surgery
- interventionNames
- Procedure: endonasal endoscopic surgery
- type
- ACTIVE_COMPARATOR
- label
- radiation therapy group
- description
- 143 participants in group 2 will undergo radiation therapy(IMRT)
- interventionNames
- Radiation: radiation therapy(IMRT)
Primary outcomes (1)
- measure
- 3 year Overall Survival (OS) rate
- timeFrame
- From date of randomization until the date of death from any cause,through study completion,up to 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study; 2. Stage T1 or T2 according to AJCC 8th edition ; 3. Aged 18 to 70 years; 4. Without metastasis; 5. previously received 1 course of radiotherapy; 6. Without radiotherapy within 1 year, without local treatment for recurrent disease; 7. Surgical resectable and IMRT suitable; 8. If regional recurrence presented, regional lesion can be treated with local treatments. 9. ECOG score 0 or 1; 10. Sufficient organ function; 11. Acceptable approach of contraception. Exclusion Criteria: 1. Refuse to sign inform consent; 2. Radiation encephalopathy or leptomeningeal disease (LMD); 3. History of radioactive particle planting; 4. Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy; 5. With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer ); 6. Any contradiction to surgery; 7. Have any co-existing condition that would preclude full compliance or safety with the study; 8. Presence of a significant neurological or psychiatric disease, including dementia and seizures; 9. Uncontrolled infectious diseases; 10. Female patients who are at pregnancy or lactation. 11. Without personal freedom or independent civil capacity. 12. With serious autoimmune disease. 13. Participants of other interventional clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.