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OpenTrials
Completed

NCT Number: NCT05923450

Tumor Deposits in Colorectal Cancers

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy

Exclusion criteria

  • Lynch syndrome
  • Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
  • colorectal cancers without metastatic nodes
  • metastatic colorectal cancers
  • eligible patients refusing adjuvant chemotherapy

Treatment and study plan

colorectal resection

Procedure

Radical resection of colorectal cancer

Primary outcomes

  1. Overall Survival

    Time frame: 5 years

    1 to 5 years overall survival

  2. Disease-free Survival

    Time frame: 5 years

    1 to 5 years disease-free survival

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Acronym: TD

Important dates

Study start
2012
Primary completion
2022
Study completion
2023
First posted
Jun 28, 2023
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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