Tumor Deposits in Colorectal Cancers (TD)

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Extranodal Extension

Treatments: Procedure: Colorectal Resection

Study type: Observational

Funder types: Other

Identifiers

NCT05923450

Vanvitelli Naples

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 243 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

243 participants in 1 patient group

Tumor Deposits

Description:

Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy

Treatment:

Procedure: Colorectal Resection