Association Between Time to Treatment and Disease-free Survival of Patients With High-risk Cutaneous Squamous Cell Carcinoma in the Head and Neck Region.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 965
- 试验地点
- 2
- 主要终点
- Association time to treatment and survival
研究概览
简要总结
The purpose of this study is to investigate the association between time to treatment (defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk cutaneous squamous cell carcinoma in the head-neck region.
详细描述
Skin cancer is the most common type of cancer in the Netherlands. Cutaneous squamous cell carcinoma (cSCC) accounts for 20% of all cutaneous malignancies. The incidence of cSCC has been rising over the years in the Netherlands, from 8,966 new cSCCs cases registered in 2012 to 14,873 cases in 2022. cSCCs mostly involve patients aged 75 years and older. Since exposure to UV radiation is the main risk factor for the development, cSCCs particularly occur on sun exposed areas of the skin such as in the head-neck region and the extremities. Other risk factors include a Fitzpatrick skin type I or II, use of immunosuppression, exposure to arsenic, and infection with human papilloma virus.
Risk of metastasis and recurrence in general cSCCs are 2.6-5% and 1.9-3.7%, respectively. However, these risk ratios may increase to 37% in high-risk cSCCs. High risk cSCCs are defined as cSCCs with risk factors for development of metastatic disease or recurrence, e.g. poor histological differentiation, perineural/lymphovascular infiltration, diameter ≥20 mm.
Due to the increasing incidence, advanced age, risk of metastasis and recurrence, and the high risk-location in the head-neck region related to functional and cosmetic importance, high-risk cSCCs in the head-neck region (high-risk HNcSCCs) require complex and multidisciplinary care. Therefore, care pathways have been developed. An important part of these care pathways are waiting times and, in particular, the time to treatment. For example, in mucosal head-neck tumors, prolonged waiting times have been described to be associated with reduced survival rates. This led to the hypothesis that prolonged waiting times result result in lower survival rates for patients with high-risk HNcSCCs. This study aimed to investigate the association between time to treatment defined as date of pathological diagnosis to date of start treatment) and disease free survival in patients with high risk HNcSCCs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient diagnosed with high-risk HNcSCCs, defined as T2 to T4 HNcSCC
- •Treated in the Maastricht University Medical Center+ (MUMC+) or Radboud University Medical Center (RadboudUMC)
- •Treated between 2010 to 2018
排除标准
- •Patients aged younger than 18 years
- •Patients with a T1 HNcSCC
- •Patients with recurrence or metastatic disease of a previously treated HNcSCC
结局指标
主要结局
Association time to treatment and survival
时间窗: 5 years after treatment
The association between time to treatment (in days) and disease-free survival (e.g. no recurrence or metastasis occurred), expressed as adjusted hazard ratio with 95% confidence intervals and p values, from multivariate Cox regression analysis.
次要结局
- 5 year disease free survival between participating centers(5 years after treatment)
- 5 year disease specific survival between short and long time to treatment(5 years after treatment)
- 5 year disease free survival between short and long time to treatment(5 years after treatment)
- 5 year overall survival between participating centers(5 years after treatment)
- 5 year overall survival between short and long time to treatment(5 years after treatment)
- 5 year disease specific survival between participating centers(5 years after treatment)