Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis

Starting soon · Not applicable

Conditions studied: Nasopharyngeal Carcinoma (NPC), Radiation Injuries, Necrosis

In brief

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.

Key facts

Study ID

NCT07552883

Run by

Jiangxi Provincial Cancer Hospital

People needed

40

Starts

2026-04-30

Expected to finish

2031-04-30

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Full record on ClinicalTrials.gov

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