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临床试验/NCT04545658
NCT04545658已完成不适用

Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2020年7月16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
167
试验地点
1
主要终点
Prediction of Acute Pulmonary Toxicity

研究概览

简要总结

(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.

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

入选标准

  • Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy

排除标准

  • Incomplete treatment

结局指标

主要结局

Prediction of Acute Pulmonary Toxicity

时间窗: Up to 6 months

The model's performance will be evaluated based on the observed rate of Acute Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).

Prediction of Late Oesophageal Toxicity

时间窗: Between 6 months and 2 years after radiotherapy

The model's performance will be evaluated based on the observed rate of Late Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).

Prediction of Acute Oesophageal Toxicity

时间窗: Up to 6 months

The model's performance will be evaluated based on the observed rate of Acute Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).

Prediction of Late Pulmonary Toxicity

时间窗: Between 6 months and 2 years after radiotherapy

The model's performance will be evaluated based on the observed rate of Late Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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