Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC)

November 30, 2020 updated by: Francesca Cravero, Santo Spirito Hospital, Italy

Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)

The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) Data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a T4 (a or b) tumour on postoperative histopathology.

Data included are patient demographics, ASA score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including TNM scoring, completeness of surgical procedure (R0 to R2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Description

Inclusion criteria

  • > 18 aa
  • Patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

Exclusion criteria

  • Stage IV
  • Rectal cancer
  • Emergency surgery (<48 hours from admission)
  • ASA > III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity
Time Frame: 30 days
I evaluate peri and post-operative surgical (e.g. intraabdominal collection, fistula, anastomotic leak) and medical (e.g. pneumoniae, deep vein thrombosis) complications
30 days
Postoperative mortality
Time Frame: 30 days
I evaluate in-hospital and 30-day mortality correlate to the intervention
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
The length of time from the intervention that patients diagnosed with a T4 colon cancer are still alive.
5 years
Disease Free Survival
Time Frame: 5 years
The measure of time after treatment during which no sign of recurrence (local or metastatic) is found.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santo Spirito Hospital, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACC Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will retrospectively collected from a maintained database in each center, created by the. A local study manager will be identified for each participating center.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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