Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT06115837
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2023-09-01
• Primary Completion: 2023-09-16
• Study Completion: 2023-09-26
• Status Verified: 2023-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer specific survival	The endpoint of the cancer specific survival assessment is the patient death due to cancer. Follow-up time is up to 72 months.	Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.
Overall survival	The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.	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.

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China