TD: Tumor Deposits in Colorectal Cancers

• Sponsor: University of Campania "Luigi Vanvitelli" (Other)
• Overall Status: Completed
• CT.gov ID: NCT05923450
• Collaborator: (none)
• Enrollment: 243
• Actual Duration (Months): 134.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Extranodal Extension	Procedure: Colorectal Resection

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 243 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official 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
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 31, 2022
• Actual Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Tumor Deposits Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy	Procedure: Colorectal Resection; Radical resection of colorectal cancer

Outcome Measures

Primary Outcome Measures

1. Overall Survival [5 years]

   1 to 5 years overall survival

2. Disease-free Survival [5 years]

   1 to 5 years disease-free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Campania "Luigi Vanvitelli"

Investigators

• Principal Investigator: Gennaro Galizia, MD, University of Campania 'Luigi Vanvitelli'

Study Documents (Full-Text)

None provided.

More Information

Publications

• Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.

• Responsible Party: Gennaro Galizia, Full Professor of Surgery, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT05923450
• Other Study ID Numbers: Vanvitelli Naples
• First Posted: Jun 28, 2023
• Last Update Posted: Jun 29, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gennaro Galizia, Full Professor of Surgery, University of Campania "Luigi Vanvitelli": tumor deposits; colorectal cancers; TNM staging system; ROC Curve
• Additional relevant MeSH terms: Colorectal Neoplasms; Extranodal Extension

Study Results

No Results Posted as of Jun 29, 2023