Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 8
- 主要终点
- Odds ratio (OR) for brain metastasis
研究概览
简要总结
Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ.
Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier.
There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain.
The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.
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
- •Patients receiving surgical treatment for esophageal cancer between 1 januari 2000 and 31 december 2019
- •All types of neoadjuvant treatment followed by surgery, primary surgery or salvage surgery.
- •Adenocarcinoma or squamous cell carcinoma histology
排除标准
- •other histology type than adenocarcinoma or squamous cell carcinoma
- •Hypopharyngeal carcinoma extending to the esophagus (requiring total laryngo-pharyngo-esophagectomy)
- •Early esophageal carcinoma (cT IS-1a N0 M0)
- •palliative esophagectomy
结局指标
主要结局
Odds ratio (OR) for brain metastasis
时间窗: 1 January 2000 - 1 March 2020
Odds ratio (OR) for brain metastasis compared between primary surgery and neoadjuvant treatment plus surgery, OR for different neoadjuvant treatment regimes, corrected for gender and tumor factors (histology, stage, tumor differentiation,...) .
次要结局
- Number of brain metastases(1 January 2000 - 1 March 2020)
- Overall survival(1 January 2000 - 1 March 2020)
- Time to recurrence(1 January 2000 - 1 March 2020)
- Characteristics of brain metastases(1 January 2000 - 1 March 2020)
- Risk factors for single site brain metastasis(1 January 2000 - 1 March 2020)