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临床试验/NCT05337631
NCT05337631招募中不适用

Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

University Hospital Freiburg18 个研究点 分布在 5 个国家目标入组 1,500 人开始时间: 2021年6月1日最近更新:
适应症

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

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

发起方
University Hospital Freiburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nils Nicolay

Professor and Vice Chair, Department of Radiation Oncology

University Hospital Freiburg

研究点 (18)

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