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临床试验/NCT05923450
NCT05923450已完成不适用

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

University of Campania "Luigi Vanvitelli"0 个研究点目标入组 243 人开始时间: 2012年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gennaro Galizia

Full Professor of Surgery

University of Campania "Luigi Vanvitelli"

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