Clinical trial · Interventional
Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis
Endoscopic Nasopharyngeal Pseudomembrane Removal for Prevention of Radiation-Induced Nasopharyngeal Necrosis After Re-irradiation in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Multicenter Interventional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma (NPC) | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Necrosis | — | UNRESOLVED | — |
| Radiation Injuries | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Nasopharyngeal Pseudomembrane Removal | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic Pseudomembrane Removal
- description
- Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic nasopharyngeal pseudomembrane removal.
- interventionNames
- Procedure: Endoscopic Nasopharyngeal Pseudomembrane Removal
Primary outcomes (1)
- measure
- 2-Year Incidence of Nasopharyngeal Necrosis
- timeFrame
- 2 years after re-irradiation
- description
- 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.
Secondary outcomes (6)
- measure
- Necrosis-Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available