Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis, NCT07552883
Summary
A prospective, single-arm, multicenter interventional study registered on ClinicalTrials.gov investigating endoscopic nasopharyngeal pseudomembrane removal in patients with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation. The trial expects to enroll 40 participants from multiple hospitals in China. The primary outcome measure is the 2-year incidence of radiation-induced nasopharyngeal necrosis, aiming to reduce the current approximate 40% incidence to 20% based on published literature.
“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.”
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What changed
This document is a ClinicalTrials.gov registration record for a new prospective, single-arm, multicenter interventional study on endoscopic nasopharyngeal pseudomembrane removal in patients with recurrent nasopharyngeal carcinoma who have received re-irradiation.
Healthcare institutions conducting international clinical trials should verify alignment between their IRB/ethics committee approvals and the trial protocol, including the endoscopic intervention, primary endpoint of 2-year nasopharyngeal necrosis incidence, and secondary safety measures. Medical device manufacturers whose endoscopic equipment may be used in this study should confirm the protocol specifications match their device indications.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis
N/A NCT07552883 Kind: NA Apr 27, 2026
Abstract
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: Endoscopic Nasopharyngeal Pseudomembrane Removal
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