Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive radiotherapy.
The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well documented, however, more and more studies are calling for the use of dosimetric parameters related to cardiac sub-structures to be integrated into clinical practice, rather than considering the heart as a whole.
With this in mind, the aim of this study is to define the parameters, particularly dosimetric ones linked to cardiac sub-structures, influencing survival in patients treated with exclusive radiotherapy or radiochemotherapy for esophageal cancer.
详细描述
Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive radiotherapy.
The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well documented, however, more and more studies are calling for the use of dosimetric parameters related to cardiac sub-structures to be integrated into clinical practice, rather than considering the heart as a whole.
Although most of these data have been studied in populations with long-term follow-up, such as breast cancer, cardiac toxicity and the reduced survival it entails are also found in diseases such as esophageal cancer.
With this in mind, the aim of this study is to define the parameters, particularly dosimetric ones linked to cardiac sub-structures, influencing survival in patients treated with exclusive radiotherapy or radiochemotherapy for esophageal cancer.
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
- 否
入选标准
- •Age ≥ 18 years
- •Histologically or cytologically proven esophageal cancer
- •Localized or locally advanced esophageal cancer treated with radiochemotherapy or exclusive radiotherapy
- •Tumor dose ≥ 50 Gy
- •Non-opposition of living patients formulated
- •Patient affiliated to a social security scheme
排除标准
- •Age < 18 years
- •Patient treated with upfront surgery
- •Tumor dose < 50 Gy
- •Other concomitant neoplasia
- •Metastatic patient
- •Refusal to participate
- •Patient under legal protection (guardianship, curatorship, etc...)
结局指标
主要结局
Overall survival (OS)
时间窗: through study completion, an average of 1 year
OS is defined as the time elapsed between inclusion and death, whatever the cause.
次要结局
- Response rate.(through study completion, an average of 1 year)
- Progression-free survival (PFS).(through study completion, an average of 1 year)
- The rate of cardiac events.(through study completion, an average of 1 year)