Endoscopic Nasopharyngeal Pseudomembrane Removal for Prevention of Radiation-Induced Nasopharyngeal Necrosis After Re-irradiation in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Multicenter Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- 2-Year Incidence of Nasopharyngeal Necrosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form.
- •Age between 18 and 80 years.
- •ECOG performance status ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
Endoscopic Pseudomembrane Removal
Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic nasopharyngeal pseudomembrane removal.
干预措施: Endoscopic Nasopharyngeal Pseudomembrane Removal (Procedure)
结局指标
主要结局
2-Year Incidence of Nasopharyngeal Necrosis
时间窗: 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.
次要结局
- Necrosis-Free Survival(Up to 2 years)
- Overall Survival(Up to 2 years)
- Progression-Free Survival(Up to 2 years)
- Local Regional Recurrence-Free Survival(Up to 2 years)
- Distant Metastasis-Free Survival(Up to 2 years)
- Safety and Adverse Events(From informed consent through 30 days after last intervention or study completion, whichever is later)
研究者
Shiyi Peng
Chief Physician, Department of Radiation Oncology
Jiangxi Provincial Cancer Hospital