Presence of Tumor Deposits is a Strong Indicator of Poor Outcome in Stage III Colorectal Cancers Undergoing Radical Surgery: Need for an Urgent Revision of the Staging System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 主要终点
- Overall Survival
研究概览
简要总结
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.
详细描述
Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected.
It has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses.
The investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.
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
- •colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy
排除标准
- •Lynch syndrome
- •Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
- •colorectal cancers without metastatic nodes
- •metastatic colorectal cancers
- •eligible patients refusing adjuvant chemotherapy
结局指标
主要结局
Overall Survival
时间窗: 5 years
1 to 5 years overall survival
Disease-free Survival
时间窗: 5 years
1 to 5 years disease-free survival
次要结局
未报告次要终点
研究者
Gennaro Galizia
Full Professor of Surgery
University of Campania "Luigi Vanvitelli"
