Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Nasopharyngeal Pseudomembrane Removal.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma (NPC), Radiation Injuries, Necrosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endoscopic Nasopharyngeal Pseudomembrane Removal for Prevention of Radiation-Induced Nasopharyngeal Necrosis After Re-irradiation in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Multicenter Interventional Study
Overview
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.
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.
Interventions
- Procedure Endoscopic Nasopharyngeal Pseudomembrane Removal
Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.
Primary outcome measures
- 2-Year Incidence of Nasopharyngeal Necrosis [Time frame: 2 years after re-irradiation]
Secondary outcome measures (6)
- Necrosis-Free Survival [Time frame: Up to 2 years]
- Overall Survival [Time frame: Up to 2 years]
- Progression-Free Survival [Time frame: Up to 2 years]
- Local Regional Recurrence-Free Survival [Time frame: Up to 2 years]
- Distant Metastasis-Free Survival [Time frame: Up to 2 years]
- Safety and Adverse Events [Time frame: From informed consent through 30 days after last intervention or study completion, whichever is later]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07552883 · 2026065-YW065