Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection

Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection: A Multi-institutional Retrospective Analysis

The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: multivisceral resection

Detailed Description

Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (MVR), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. In this study, investigators attempted to evaluate the prognostic factors of pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pT4bN0M0 patients.

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patient experienced multivisceral resection for pT4bN0M0 colorectal cancer from January 2010 to December 2021.

Description

Inclusion Criteria:

1. The patient was pathologically diagnosed as colorectal adenocarcinoma.
2. Patients with pT4bN0M0 colorectal cancer.
3. Patients with R0 resection.

Exclusion Criteria:

1. Patients with distant metastasis.
2. Patients with R1 or R2 resection.
3. Patients with lymph node metastasis
4. Recurrent colorectal cancer.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.	The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
Cancer specific survival	Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.	The endpoint of the cancer specific survival assessment is the patient death due to cancer. Follow-up time is up to 72 months.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): September 16, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Prognosis; Colorectal Cancer; Multivisceral resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NCC2330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No