Nasopharyngeal Carcinoma (NPC)EPoRNNCT07552883
Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis
A study testing Endoscopic Nasopharyngeal Pseudomembrane Removal in people with Nasopharyngeal Carcinoma (NPC) and Radiation Injuries, run by Jiangxi Provincial Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), Radiation Injuries, Necrosis
- What is being tested?
- Endoscopic Nasopharyngeal Pseudomembrane Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 30 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma (NPC), Radiation Injuries, Necrosis
- Being tested
- Endoscopic Nasopharyngeal Pseudomembrane Removal
- Keywords
- recurrent NPC, re-RT, radiation necrosis, pseudomembrane, endoscopy
- Medical subject headings
- Nasopharyngeal Carcinoma, Radiation Injuries, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Nasopharyngeal Pseudomembrane RemovalProcedure or surgery
Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Pseudomembrane Removal | Experimental | Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic nasopharyngeal pseudomembrane removal. Receives: Procedure: Endoscopic Nasopharyngeal Pseudomembrane Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after re-irradiation
Secondary outcomes (6)
Necrosis-Free Survival
Time from study enrollment to the first occurrence of nasopharyngeal necrosis or death from any cause, whichever occurs first.
Measured: Up to 2 years
Overall Survival
Time from study enrollment to death from any cause.
Measured: 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.
Measured: Up to 2 years
Local Regional Recurrence-Free Survival
Time from study enrollment to first local or regional recurrence of nasopharyngeal carcinoma.
Measured: Up to 2 years
Distant Metastasis-Free Survival
Time from study enrollment to first detection of distant metastasis.
Measured: 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
Measured: From informed consent through 30 days after last intervention or study completion, whichever is later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyi Peng, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552883
- Sponsor's protocol ID
- 2026065-YW065
- Acronym
- EPoRN
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07552883
- Acronym / sponsor ID
- EPoRN / 2026065-YW065
- Conditions
- Nasopharyngeal Carcinoma (NPC), Radiation Injuries, Necrosis
- Keywords
- recurrent NPC, re-RT, radiation necrosis, pseudomembrane, endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Pseudomembrane Removal | Experimental | Procedure: Endoscopic Nasopharyngeal Pseudomembrane RemovalParticipants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic nasopharyngeal pseudomembrane removal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Nasopharyngeal Pseudomembrane RemovalEndoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments. | Procedure or surgery | Endoscopic Pseudomembrane Removal |
Primary outcome
2-Year Incidence of Nasopharyngeal Necrosis
Time frame: 2 years after re-irradiation
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Nasopharyngeal Pseudomembrane Removal in people with Nasopharyngeal Carcinoma (NPC) and Radiation Injuries, run by Jiangxi Provincial Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziwei Tu (13755793552, tuziwei198803@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Incidence of Nasopharyngeal Necrosis (time frame: 2 years after re-irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.