Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.

Colorectal Cancer Clinical Trial

Official title:

Does Delaying Curative Surgery for Colorectal Cancer Influence Long-term Disease Free Survival.: A COHORT STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430231
• Other study ID #: 2019/285
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: April 1, 2020

Study information

• Verified date: June 2020
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This work is an original clinical research article describing the relationship between wait list tome for colorectal cancer patients and long-term survival. These findings are particularly relevant for management of surgical wait lists during crisis such as the Covid-19 pandemic. The lack of a relationship between wait list time and disease free survival and tendency for improved survival in the 4-6 week imply some colorectal cancer operations can be safely delayed during times of limited resources.

Description:

Background Surgical wait list time is a major problem in many health-care systems and its influence on survival is unclear. The aim of this study is to assess the impact of the wait list time on long term disease-free survival in patients scheduled for colorectal cancer resection.

Materials and Methods A prospective, single center study was carried out in patients with stage I-III colorectal cancer scheduled for surgery between 2012-2017 at a Colorectal Surgery Unit of a tertiary care center. Wait list time was defined as the time from completion of diagnostic workup and definitive surgery and divided into 2-week intervals from 2 to 6 weeks. The outcome variables were 2- and 5-year disease free survival. Screening for disease progression was with carcinoembryonic antigen levels and chest/abdominal computed tomography scan. Data was collected prospectively and subsequently analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: April 1, 2020
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas

• With "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

Exclusion Criteria:

• Emergency surgery,

• More than one primary site,

• Synchronous metastasis or peritoneal carcinomatosis at the time of surgery

• If they received neoadjuvant chemoradiotherapy

• If they had a local transanal excision.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Wait list time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free overall survival		5 years