Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis (EPoRN)

Endoscopic Nasopharyngeal Pseudomembrane Removal for Prevention of Radiation-Induced Nasopharyngeal Necrosis After Re-irradiation in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Multicenter Interventional Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Necrosis; Radiation Injuries; Nasopharyngeal Carcinoma (NPC)
• Intervention / Treatment: Procedure: Endoscopic Nasopharyngeal Pseudomembrane Removal

Detailed Description

Study Design: This is a prospective, single-arm, multicenter interventional study without randomization or blinding. The study will be conducted at three hospitals in China: Jiangxi Provincial Cancer Hospital, The Fifth Affiliated Hospital of Sun Yat-sen University, and The First Affiliated Hospital of Nanchang University. A total of 40 participants will be enrolled.

Sample Size Calculation: Based on published literature, the 2-year incidence of radiation-induced nasopharyngeal necrosis after re-irradiation (re-RT) in patients with recurrent nasopharyngeal carcinoma is approximately 40%. This study expects to reduce the incidence to 20%. With a one-sided alpha of 0.05 and power of 80% (beta = 0.20), the calculated sample size is 36 patients. Considering a 10% dropout or loss to follow-up rate, the target enrollment is 40 patients.

Inclusion Criteria (key): Age 18-80 years; ECOG ≤ 2; prior radical radiotherapy with dose ≥ 66Gy; imaging or histopathology confirmed local recurrence and/or retropharyngeal lymph node recurrence with or without cervical lymph node recurrence; re-irradiation with single dose < 2.3Gy and total dose ≥ 50Gy; presence of pseudomembrane reaction on nasopharyngeal mucosa during or after re-irradiation; expected survival > 1 year; induction chemotherapy, immunotherapy, concurrent chemotherapy, adjuvant chemotherapy, or radiotherapy alone are all permitted.

Intervention Procedure: Endoscopic nasopharyngeal pseudomembrane removal will be performed by experienced otolaryngologists. The procedure is carried out in patients with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation.

Follow-up Schedule: Participants will be followed up every 3 months for 2 years after the intervention. Follow-up assessments include nasopharyngeal endoscopy, imaging studies (MRI or CT), symptom evaluation, and recording of adverse events.

Statistical Methods: The primary outcome (2-year incidence of nasopharyngeal necrosis) will be reported as a proportion with 95% confidence interval. Secondary outcomes including necrosis-free survival, overall survival, progression-free survival, local regional recurrence-free survival, and distant metastasis-free survival will be analyzed using Kaplan-Meier methods. Safety will be assessed by summarizing the type, frequency, and severity of adverse events.

Data Monitoring and Safety: Adverse events will be collected from the time of informed consent through the end of the study follow-up. Serious adverse events will be reported to the ethics committee and regulatory authorities according to local requirements.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziwei Tu; Phone Number: 13755793552; Email: tuziwei198803@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntarily sign the informed consent form.
• Age between 18 and 80 years.
• ECOG performance status ≤ 2.
• Prior radical radiotherapy with total dose ≥ 66 Gy.
• Imaging or histopathology confirmed local recurrence and/or retropharyngeal lymph node recurrence, with or without cervical lymph node recurrence.
• Re-irradiation with single dose < 2.3 Gy and total dose ≥ 50 Gy.
• Presence of pseudomembrane reaction on nasopharyngeal mucosa during or after re-irradiation.
• Expected survival > 1 year.
• Induction chemotherapy, immunotherapy, concurrent chemotherapy, adjuvant chemotherapy, or radiotherapy alone are all permitted.

Exclusion Criteria:

• History of other malignancies within the past 5 years, except cured non-melanoma skin cancer or carcinoma in situ of the cervix.
• Severe uncontrolled systemic diseases (e.g., uncontrolled infection, severe cardiovascular disease, uncontrolled diabetes).
• Pregnant or breastfeeding women.
• Known allergy to any equipment or medication used during endoscopy.
• Inability to tolerate endoscopic procedure due to anatomical or medical reasons.
• Concurrent participation in another interventional clinical trial.
• Any condition that, in the investigator's judgment, would interfere with study compliance or outcome assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic Pseudomembrane Removal; Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic nasopharyngeal pseudomembrane removal.	Procedure: Endoscopic Nasopharyngeal Pseudomembrane Removal; Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-Year Incidence of Nasopharyngeal Necrosis	The proportion of participants who develop radiation-induced nasopharyngeal necrosis within 2 years after re-irradiation, as confirmed by endoscopic and/or imaging (MRI/CT) findings.	2 years after re-irradiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Necrosis-Free Survival	Time from study enrollment to the first occurrence of nasopharyngeal necrosis or death from any cause, whichever occurs first.	Up to 2 years
Overall Survival	Time from study enrollment to death from any cause.	Up to 2 years
Progression-Free Survival	Time from study enrollment to disease progression (local, regional, or distant) or death from any cause, whichever occurs first.	Up to 2 years
Local Regional Recurrence-Free Survival	Time from study enrollment to first local or regional recurrence of nasopharyngeal carcinoma.	Up to 2 years
Distant Metastasis-Free Survival	Time from study enrollment to first detection of distant metastasis.	Up to 2 years
Safety and Adverse Events	Type, frequency, severity, and causality of adverse events as assessed by CTCAE v5.0 (or applicable version). Including procedure-related complications such as bleeding, perforation, infection, and pain	From informed consent through 30 days after last intervention or study completion, whichever is later

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: endoscopy; radiation necrosis; recurrent NPC; re-RT; pseudomembrane
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Pathological Conditions, Signs and Symptoms; Nasopharyngeal Carcinoma; Necrosis; Radiation Injuries
• Other Study ID Numbers: 2026065-YW065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No