Prediction Models for Complications After CRT in Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 8
- 主要终点
- Mortality
研究概览
简要总结
The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer
详细描述
Plan of investigation
In the present project we aim to evaluate two potential strategies to predict and consider a broad spectrum of complications for radiotherapy plan optimization and patient selection:
A comprehensive set of separate NTCP-models for several cardiopulmonary and post-operative complications after nCRT, which results in an NTCP-profile.
A single multivariable NTCP-model for a so-called Complication Sum Score (CSS), which is a single composite complication endpoint including all complications after nCRT, weighted depending on severity and impact.
These prediction models can be used for RT plan optimization and patient selection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor in the esophagus, histologically proven or suspect for esophageal carcinoma
- •WHO performance 0-2
- •Age>18years
- •No distant metastasis (M0)
- •Treated with nCRT and planned for or followed by an esophagectomy between 2015 and 2021 in one of the participating centers.
排除标准
- •Sarcoma, neuro-endocrine or small cell carcinoma of the esophagus
- •Patients who underwent a surgical resection in a non-participating surgical center will be excluded
结局指标
主要结局
Mortality
时间窗: 1 and 2 year after nCRT
Mortality
Cardiac events grade II or higher (CTCAE v 5.0), including:
时间窗: 1 and 2 year after nCRT
Pericardial effusion Myocardial infarction and other acute coronary events Heart failure Pericardial effusion Myocardial infarction and other acute coronary events Heart failure Atrial fibrillation
Multivariable NTCP models will be developed for the prediction of the following
时间窗: Within 90 days after surgery
Postoperative complications (graded by ECCG classification (3) ): Atrial fibrillation ≥grade 2 Pneumonia ≥grade 2 Respiratory failure requiring re-intubation Anastomotic leakage ≥ grade 2
Complication Sum Score, that will be determined in Delphi consensus
时间窗: 1 year after nCRT
Complication Sum Score, that will be determined in Delphi consensus
次要结局
- Patient-rated fatigue / daily functioning(Up to 6 months after nCRT)
- Hospitalization after esophagectomy (days)(Hospitalization after esophagectomy, average 12 days)
- Intensive care unit stay after esophagectomy (days)(Intensive care unit stay after esophagectomy, average 1.5 days)
- Patient-rated nausea(Up to 30 day after nCRT)
- Patient-rated dysphagia(Up to 30 days after nCRT)