NCT05432219尚未招募不适用
Endoscopic Transoral Retropterygoid Nasopharyngectomy in Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Exploratory Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Margin-negative (R0) resection rate
研究概览
简要总结
This is a a prospective, single-arm, and exploratory study of endoscopic resection of recurrent nasopharyngeal carcinoma via transoral retropterygoid approach.
详细描述
The present study explored a novel transoral retropterygoid approach to resect recurrent nasopharyngeal carcinoma, aiming to investigate the effectiveness of this novel approach in the treatment of recurrent nasopharyngeal carcinoma. The primary end point was the margin-negative (R0) resection rate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
- •AJCC rT2-T4 which can be surgically removed.
- •No distant metastasis.
- •aged 18 or more than 18 years old.
- •With or without lymph node metastasis, which can be surgically removed.
- •No severe restricted mouth opening, and oral approach eligible.
- •Sufficient organ function.
- •With signed informed consent.
- •ECOG score 0-2, and general physical condition can tolerate general anesthesia surgery.
排除标准
- •Primary nasopharyngeal carcinoma
- •The patient has surgical contraindications: such as severe cardiopulmonary disease and coagulation dysfunction, etc.
- •The patient has any situation that may hinder study compliance or the safety during the study period.
- •Suffer from uncontrolled disease which could interfere with treatment.
- •Uncontrolled active infection.
- •Pregnant or breastfeeding women
- •There are some other situations that are not suitable for entry into the study.
研究组 & 干预措施
Endoscopic Transoral Retropterygoid Nasopharyngectomy
Experimental
a novel endoscopic approach to resect nasopharyngeal carcinoma
干预措施: endoscopic surgery (Procedure)
结局指标
主要结局
Margin-negative (R0) resection rate
时间窗: once the pathology results come out, up to 14 days
The rate of the margin-negative resection of the nasopharyngeal carcinoma
次要结局
- Rate of a complete resection based on imaging findings(within 7 days after surgery)
- bleeding volume in surgery(From the beginning to the end of the surgery)
- Operating time(From the beginning to the end of the surgery)
- Surgery-associated restricted mouth opening(at 30 days post surgery)
- Disease-free survival (DFS)(From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years)
- local recurrence-free survival (LRFS)(From the date of enrollment to local recurrence or death, up to 2 years)
- quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life(From the date of enrollment to the end of study, up to2 years)
- quality of life-(EORTC QLQ) -H&N35(From the date of enrollment to the end of study, up to 2 years.)
- surgery-associated adverse effect(From the date of surgery to the end of study, up to 2 years.)
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