Study of Oncological Outcomes of D3 Lymph Node Dissection in Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 780
- 试验地点
- 24
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine wether D3 lymph node dissection gives superior oncological outcomes compared to standard D2 lymph node dissection in colon cancer
详细描述
The design involves random allocation of eligible patients to D3 or D2 lymph node dissection group in 1:1 ratio. The extent of colonic resection itself is not influenced by the randomization and is predefined by the investigator prior to randomization.
Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience with evaluation of non-edited video-recordings of procedures.
Routine quality control includes requirement to photograph vessels with the clip to determine the extent of lymph node dissection performed and a thorough morphological assessment of the specimen.
After surgery patients are treated according to local standards with no difference wether D2 or D3 lymph node dissection was performed. Short-term and long-term outcomes are registered as per protocol.
This is a superiority trial evaluating statistical superiority. With the 50% five year survival according to national registry for colon cancer, expecting 10% improvement in survival with D3 lymph node dissection, enrollment of 768 patients during 3 year accrual period followed by 5 year follow up is required for a power of 80%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
- •clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
- •indications for surgical colonic resection
- •ECOG status 0-2
- •At least 18 years of age
- •Written informed consent
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
- •Pregnancy or breast feeding
- •Medical contraindications for surgical treatment
- •Synchronous or metachronous malignancy
- •Non-resectable distant metastases
- •Colon obstruction, perforation or bleeding complicating the tumor
- •Indications for isolated transverse colon resection
- •Neoadjuvant chemotherapy
结局指标
主要结局
Overall survival
时间窗: 5 years after last patient enrolled
overall survival of patients
次要结局
- Disease-free survival(5 years after last patient enrolled)
- Pattern of lymph node metastasis based on pathology report(enrollment period)
- CME quality(enrollment period)
- Postoperative morbidity(within the first 30 days after surgery)
- Postoperative recovery parameters(within the first 30 days after surgery)
- Postoperative mortality(within the first 30 days after surgery)
- Quality of life in patients after D2 and D3 lymph node dissection using questionnaire(enrollment period)
- Lymph node yield(enrollment period)