Correlation of Radiotherapy-related Features With Postoperative Complications in Patients With Esophageal Cancer Treated With Trimodality Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
The purpose of this study is to identify features of the cumulative dose-volume histogram (DVH) for patients treated with trimodality therapy in oesophageal cancer and correlate these with postoperative complications.
详细描述
Intention to treat analysis in patients initially assigned to be treated with the trimodality protocol: neoadjuvant chemoradiotherapy followed by surgery.
The investigators will retrospectively evaluate several parameters of the treatment planning of patients treated with a preoperative regimen (CROSS regimen 41,4 Gy in 23 fractions or 50, 4 Gy in 28 fractions ):
- PTV volume1
- MLD, V30, V20, V15, V10, VS5 (Volume lung less dan 5 Gy)2 (lung toxicity)
- MHD, V20, V30, V403 (heart toxicity)
- Mean stomach dose, V50 stomach
- Mitochondrial DNA if available per patient Pre-existing cardiac,pulmonary comorbidity, smoking behavior, BMI, type of surgery and chemotherapy (especially taxanes) will be scored and take into account in a multivariate analysis. The investigators will collect these data and correlate the data with the presence of postoperative complications, time of onset of complications and duration of hospitalization. These latter data are already scored in a prospective manner at the Atrium Medical Center in Heerlen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oesophageal cancer patients
- •initially treated with a preoperative dose of radiation in combination with chemotherapy and subsequently undergone surgical resection
排除标准
- •Patients who were treated with definitive chemoradiation or palliative radiotherapy
结局指标
主要结局
Postoperative complications
时间窗: within 30 and 90 Days after operation
Cardiac complications (arrhythmia etc ) * Respiratory complications (pneumonia, pleural effusion etc) * Anastomotic leakage * Postoperative 30-day mortality * Total postoperative mortality * Treatment-related mortality * Hospitalization and stay at intensive care unit duration
次要结局
未报告次要终点