Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis

NCT07552883 | Not Yet Recruiting DMC

• 1 other identifier: 2026065-YW065
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

recurrent NPC; re-RT; radiation necrosis; pseudomembrane; endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Necrosis-Free Survival

  Up to 2 years

• Overall Survival

  Up to 2 years

• Progression-Free Survival

  Up to 2 years

• Local Regional Recurrence-Free Survival

  Up to 2 years

• Distant Metastasis-Free Survival

  Up to 2 years

Study Arms (1)

Endoscopic Pseudomembrane Removal

EXPERIMENTAL

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

Interventions

Endoscopic Nasopharyngeal Pseudomembrane Removal PROCEDURE

Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.

Endoscopic Pseudomembrane Removal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Radiation Injuries; Necrosis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ziwei Tu

CONTACT

13755793552; tuziwei198803@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Radiation Oncology

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share