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

Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 Clinical Trial

— LACC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04646772
• Other study ID #: LACC Trial
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2020
• Source: Santo Spirito Hospital, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4
• Neoplasms

Intervention

Procedure:
• Multivisceral resection
Multivisceral resection for locally advanced colon cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santo Spirito Hospital, Italy

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity	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
Primary	Postoperative mortality	I evaluate in-hospital and 30-day mortality correlate to the intervention	30 days
Secondary	Overall Survival	The length of time from the intervention that patients diagnosed with a T4 colon cancer are still alive.	5 years
Secondary	Disease Free Survival	The measure of time after treatment during which no sign of recurrence (local or metastatic) is found.	5 years