Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- effectiveness of post-operative radiotherapy in preventing local and regional recurrences
研究概览
简要总结
Post-operative radiotherapy (PORT) is currently considered as the second most important therapy to treat high-grade cutaneous squamous cell carcinoma. Nonetheless, only few studies evaluate its impact on recurrence rate and the major part of those ones do not include a proper control group of patients.
Most recent guide lines from NCCN, Sidemast and British associations of dermatologists suggest clinicians to offer or consider PORT in selected patients but class nor level of evidence of those guide lines are provided.
This project evaluates impact of post-operative radiotherapy on recurrence rate and overall survival by comparing two cohort of patients, the former who accepted PORT and the latter who, nonetheless its necessity, decided to not undergo it.
The hypothesis which this project will answer concerns the effectiveness of post-operative radiotherapy in preventing local and regional recurrences. We expect a significant decrease of recurrence rate in patients who undergo this therapeutic option as compared to those with clinical indication but do not undergo PORT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •diagnosis of high-grade cutaneous squamous cell carcinoma
- •patients eligible for post-operative radiotherapy
- •minimum follow-up of 24 months
排除标准
- •lack of clinical of histological data
- •impossibility of a proper follow-up
- •occurrence of intermediate events (i.e., pregnancy)
结局指标
主要结局
effectiveness of post-operative radiotherapy in preventing local and regional recurrences
时间窗: 24 months
Association of PORT and recurrence rate, considering PORT as a binary variable (yes/no) and evaluating recurrence with a clinical and echographic follow-up with a minimum duration of 24 months.
次要结局
未报告次要终点
研究者
Chiara Giorgini
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
