Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 2-year local recurrence rate
研究概览
简要总结
The incidence of laryngeal cancer accounts for about 1 ~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •adults over the age of 18;
- •radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines);
- •the expected survival time ≥ 3 months;
- •sign informed consent for treatment and research with self-knowledge.
排除标准
- •there is distant metastasis;
- •pregnant women;
- •patients with CT/MRI contraindications;
- •the patient fails to receive treatment and/or follow-up as scheduled;
- •bad fluid and organ function decompensation;
- •multiple primary cancers;
- •patients participating in other trials.
结局指标
主要结局
2-year local recurrence rate
时间窗: 2 year
In this study, no matter whether distant metastases occurred, if there was the presence of any anastomotic or lateral node recurrences, it was defined as local recurrence. Criteria for local recurrence include (1) MRI results suggests local tumor recurrence, (2)Laryngoscopy indicates local tumor recurrence.
次要结局
- 2-year overall survival(2 years)
- tissue necrosis(2 years)
- 2-year disease free survival(2 years)
- fibrosis(2 years)
- time of wound healing(up to 1 month)
研究者
LiLi
director of head and neck surgery division
Tianjin First Central Hospital