Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 18
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.
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
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx
- •primary treatment since 2005
- •age ≥65 years at the time of (chemo-)radiotherapy
排除标准
- •adjuvant (chemo-)radiotherapy
- •history of previous head-and-neck cancers or radiotherapy in the head-and-neck region
- •distant metastases at (chemo-)radiotherapy initiation (cM1)
- •HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 5 years
Time from radiotherapy start until death from any cause
次要结局
- Progression-free survival (PFS)(Up to 5 years)
研究者
Nils Nicolay
Professor and Vice Chair, Department of Radiation Oncology
University Hospital Freiburg
