Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases (Node)
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
研究概览
详细说明
Objective: To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine the effect on survival and recurrence.
Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level III and/ or IV.
Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation.
Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the Modified Clavien-Dindo classification. Secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Utrecht、荷兰、3584 CX
- UMC Utrecht
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus.
- Surgical resectable carcinoma (T1-4a, N1-3) (table 1)
- Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV
- Age ≥ 18
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Written informed consent
Exclusion Criteria:
- Distant metastases
- Esophageal carcinoma < 3 cm beneath UES
- Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
- Former radiotherapy or chemotherapy for esophageal carcinoma
- Former radiotherapy precluding radiotherapy according the CROSS protocol
- Inadequate pulmonary function disabling transthoracic resection
- >10% loss of weight in the last six months
- Previous neck dissection
- New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：surgery
esophagectomy with three-field lymphnode dissection
|
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
大体时间：5 years
|
Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
|
5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mortality
大体时间：5 years
|
in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)
|
5 years
|
|
survival
大体时间：5 years
|
5 year overall- and disease free survival.
|
5 years
|
|
quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
大体时间：10 years
|
QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
|
10 years
|
|
operation related events 1
大体时间：5 years
|
duration of surgery (minutes)
|
5 years
|
|
operation related events 2
大体时间：5 years
|
reason for prolongation of surgery if applicable
|
5 years
|
|
operation related events 3
大体时间：5 years
|
unexpected events/ complications
|
5 years
|
|
operation related events 4
大体时间：5 years
|
bloodloss (ml) reason for conversion if applicable.
|
5 years
|
|
operation related events 5
大体时间：5 years
|
reason for conversion if applicable.
|
5 years
|
|
postoperative recovery
大体时间：5 years
|
duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),
|
5 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
pathology results 1
大体时间：5 years
|
pTNM stage
|
5 years
|
|
pathology results 2
大体时间：5 years
|
site of tumour
|
5 years
|
|
pathology results 3
大体时间：5 years
|
length of tumour
|
5 years
|
|
pathology results 4
大体时间：5 years
|
type of tumour
|
5 years
|
|
pathology results 5
大体时间：5 years
|
gradation of tumour
|
5 years
|
|
pathology results 6
大体时间：5 years
|
margins of resection (R0, R1, R2)
|
5 years
|
|
pathology results 7
大体时间：5 years
|
mandard score
|
5 years
|
|
pathology results 8
大体时间：5 years
|
lymphnode status
|
5 years
|
|
pathology results 9
大体时间：5 years
|
vaso-invasion
|
5 years
|
|
pathology results 10
大体时间：5 years
|
perineural growth
|
5 years
|
合作者和调查者
赞助
调查人员
- 首席研究员：Richard V Hillegersberg, Prof Dr、UMCU
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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