Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
研究概览
简要总结
There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. However, in Western countries patients with cervical lymph node metastases are generally precluded from curative treatment.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- •Written informed consent
排除标准
- •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
结局指标
主要结局
Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
时间窗: 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)
次要结局
- postoperative recovery(5 years)
- mortality(5 years)
- operation related events 3(5 years)
- operation related events 4(5 years)
- operation related events 1(5 years)
- operation related events 5(5 years)
- quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)(10 years)
- operation related events 2(5 years)
- survival(5 years)