Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis
NCT07552883 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-27
Summary
This study aims to evaluate the effectiveness and safety of endoscopic nasopharyngeal pseudomembrane removal in reducing radiation-induced nasopharyngeal necrosis in patients with recurrent nasopharyngeal carcinoma who have received re-irradiation. This is a prospective, single-arm, multicenter interventional study. Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic pseudomembrane removal. Based on published literature, the 2-year incidence of radiation-induced nasopharyngeal necrosis after re-irradiation is approximately 40%. This study expects to reduce the incidence to 20%. The primary outcome measure is the 2-year incidence of nasopharyngeal necrosis after re-irradiation. Secondary outcome measures include: necrosis-free survival, overall survival, progression-free survival, local regional recurrence-free survival, distant metastasis-free survival, as well as safety and adverse events. A total of 40 participants will be enrolled from multiple hospitals in China.
Conditions
- Nasopharyngeal Carcinoma (NPC)
- Radiation Injuries
- Necrosis
Interventions
- PROCEDURE
-
Endoscopic Nasopharyngeal Pseudomembrane Removal
Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.
Sponsors & Collaborators
-
Jiangxi Provincial Cancer Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2029-04-30
- Completion
- 2031-04-30
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