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临床试验/NCT04731571
NCT04731571已完成不适用

Toward High Fidelity Adaptive Radiotherapy in the Thorax

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
The number of patients with treatment-related Grade 3 or higher adverse cardiac events as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 2 years

研究概览

简要总结

Daily adaptive radiotherapy with individualized planning margins for thoracic and pelvic cancer patients will increase the potential of reducing dose to OARs, thereby reducing treatment-related toxicities and ultimately providing these patients with a better quality of life. Thus, the overarching objective of this work is to develop a CBCT-guided adaptive workflow and to measure the benefits to patients of the adaptive treatment paradigm utilizing patient reported outcomes in a first-of-kind study.

详细描述

  1. To individualize the planning margins used for treatment, we will assess the impact of the different uncertainties on patient-specific planning margins. We determine the dosimetric uncertainties for patients during planning and delivery through the daily adaptive process. In so doing, we will determine the relationship between the dose distributions and the associated treatment outcomes.
  2. To perform retrospective clinical studies using patient data, we determine the relationship between dosimetry from plans developed using the optimized patient-specific margins (plans from (1) that are robust to uncertainties) and retrospective, clinical outcomes. This data will be used to inform daily adaptation and plan quality criteria for a prospective clinical protocol.
  3. To develop (with our clinical collaborators) a first-of-kind study to measure the efficacy of daily adaptive treatment with individualized planning margins, using clinical and quality of life (patient reported) outcomes, and to compare these against the conventional treatment approach, where a single treatment plan with population-based treatment margins is utilized for all treatment fractions.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Histologically confirmed non-small cell lung cancer patients
  • Locally advanced

排除标准

  • 未提供

结局指标

主要结局

The number of patients with treatment-related Grade 3 or higher adverse cardiac events as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 2 years

时间窗: through study completion, an average of 2 years

A set of treatment planning strategies were designed and retrospectively implemented for locally advanced, non-small cell lung cancer (NSCLC) patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Kim

Medical Physicist

Henry Ford Health System

研究点 (1)

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