Pseudomembrane Removal for Post-RT Nasopharyngeal Necrosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiangxi Provincial Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the informed consent form.
Age between 18 and 80 years.
ECOG performance status ≤ 2.
Prior radical radiotherapy with total dose ≥ 66 Gy.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic Nasopharyngeal Pseudomembrane Removal
Procedure/SurgeryEndoscopic visualization of nasopharynx, identification of pseudomembrane, and complete removal using endoscopic instruments.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Endoscopic Pseudomembrane RemovalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-irradiationSecondary outcomes
1
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 years2
Overall Survival
Time from study enrollment to death from any cause.
Time frame
Up to 2 years3
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 years4
Local Regional Recurrence-Free Survival
Time from study enrollment to first local or regional recurrence of nasopharyngeal carcinoma.
Time frame
Up to 2 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: