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临床试验/NCT02284308
NCT02284308进行中(未招募)不适用

ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy

Maastricht Radiation Oncology22 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
180
试验地点
22
主要终点
Correlation GA with QAS (quality adjusted survival)

研究概览

简要总结

There is no detailed information available on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to distinguish the subgroup of fit patients from frail patients.

详细描述

Lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. Due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. Concurrent radiochemotherapy (RCHT) has been recognised as the standard treatment of stage III NSCLC patients with a good performance status. Evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. Furthermore, the survival gain obtained with combined RCHT, comes with a significant increase in toxicity. Therefore, information on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of medically fit elderly patients is still lacking. Moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation GA with QAS (quality adjusted survival)

时间窗: 5 years

To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years

次要结局

  • Flow chart(5 years)
  • Medical comparison between treatments(5 years)
  • Geriatric assessment(Baseline)
  • Cost-effectiveness(End of study)
  • Predictive value(5 years)
  • Development and validation of geriatric screening instrument(5 years)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (22)

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