An interventional study of Endoscopic Nasopharyngeal Pseudomembrane Removal in Nasopharyngeal Carcinoma (NPC), Radiation Injuries and Necrosis, sponsored by Jiangxi Provincial Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Jiangxi Provincial Cancer Hospital · Not applicable, Interventional, and Treatment
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.
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.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Jiangxi Provincial Cancer Hospital is the lead sponsor of 34 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Endoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.
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.
Time frame: 2 years after re-irradiation
Necrosis-Free Survival
Time from study enrollment to the first occurrence of nasopharyngeal necrosis or death from any cause, whichever occurs first.
Time frame: Up to 2 years
Overall Survival
Time from study enrollment to death from any cause.
Time frame: 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.
Time frame: Up to 2 years
Local Regional Recurrence-Free Survival
Time from study enrollment to first local or regional recurrence of nasopharyngeal carcinoma.
Time frame: Up to 2 years
Distant Metastasis-Free Survival
Time from study enrollment to first detection of distant metastasis.
Time frame: 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
Time frame: From informed consent through 30 days after last intervention or study completion, whichever is later
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Apr 2029, 36 months later.
Of 49 interventional studies with no phase under Nasopharyngeal Carcinoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Jiangxi Provincial Cancer Hospital