Survival Outcomes by Tumor-Node Stage and Recurrence Patterns in Colon Cancer After Radical Surgery

NCT07167147 | Completed DMC

• 1 other identifier: 202500389B0
• Study Type: observational
• Target: 7,259
• Locations: 1 country
• Sites: 1

Brief Summary

Colon cancer is one of the most common cancers worldwide, and even after curative (radical) surgery, some patients develop recurrence or distant metastasis. Understanding how tumor stage and lymph node status at the time of diagnosis influence the risk and patterns of recurrence is important for guiding follow-up and treatment strategies. This study retrospectively evaluates patients with stage I-III colon cancer who underwent radical surgery at Chang Gung Memorial Hospital between 2006 and 2018. A total of 7,259 patients are included from the institutional tumor registry. Patients are categorized into four tumor-node (TN) stage groups:

• T1-3 without lymph node involvement
• T1-3 with lymph node involvement
• T4 without lymph node involvement
• T4 with lymph node involvement The study aims to examine recurrence patterns (no recurrence, local recurrence, isolated lung metastasis, isolated liver metastasis, or multiple sites) and overall survival. Statistical analyses planned include Kaplan-Meier survival analysis and marginal structural models to compare outcomes across different TN stages and recurrence types. This study is based on retrospective data and was approved by the Institutional Review Board of Chang Gung Memorial Hospital (IRB No: 202500389B0). No new patient enrollment or interventions will be performed, and patient consent was waived due to the retrospective nature of the study.

Conditions

Colon Cancer; Colon Adenocarcinoma; Colon Cancer Stage III; Colon Cancer Stage I; Colon Cancer Stage II; Cancer Recurrence; Survival Analysis

Keywords

Colon Cancer; Colon Adenocarcinoma; Stage I-III Colon Cancer; Tumor-Node Stage; TN Staging; Cancer Recurrence; Recurrence Patterns; Survival Outcomes; Radical Surgery; Prognostic Factors; Retrospective Cohort

Outcome Measures

Primary Outcomes (2)

• Recurrence Patterns After Radical Surgery in Stage I-III Colon Cancer

  Recurrence classified as no recurrence, local recurrence, isolated lung metastasis, isolated liver metastasis, or multiple-site metastases, based on imaging and clinical follow-up data.

  From date of radical surgery until the date of first documented recurrence, assessed up to 60 months.

• Overall Survival After Radical Surgery in Stage I-III Colon Cancer

  Defined as the time from surgery to death from any cause, assessed using hospital records and national death registry data.

  From date of radical surgery until death from any cause, assessed up to 5 years.

Secondary Outcomes (4)

• Disease-Free Survival

  From date of radical surgery until the date of recurrence or death from any cause, whichever comes first, assessed up to 5 years.

• Cancer-Specific Survival (CSS)

  From date of radical surgery until death specifically attributable to colon cancer, assessed up to 5 years.

• All-Cause Mortality by Recurrence Pattern

  From date of first documented recurrence until death from any cause, assessed up to 5 years.

• Prognostic Impact of Tumor-Node Stage

  From date of diagnosis and radical surgery until the date of first documented recurrence or metastasis, assessed up to 5 years.

Study Arms (4)

T1-3N-

Patients with stage I-III colon adenocarcinoma, T1-3 tumors without lymph node involvement.

T1-3N+

Patients with stage I-III colon adenocarcinoma, T1-3 tumors with lymph node involvement.

T4N-

Patients with stage I-III colon adenocarcinoma, T4 tumors without lymph node involvement.

T4N+

Patients with stage I-III colon adenocarcinoma, T4 tumors with lymph node involvement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included 7,259 patients with stage I-III colon adenocarcinoma who underwent curative resection at Chang Gung Memorial Hospital (Linkou, Taiwan) between 2006 and 2018. Patients were categorized into four groups according to tumor and nodal status: T1-3N-, T1-3N+, T4N-, and T4N+. Clinical, pathological, and survival data were collected from the institutional tumor registry for retrospective analysis.

You may qualify if:

• Patients with histologically confirmed colon adenocarcinoma
• Stage I-III disease at diagnosis
• Underwent curative (radical) resection at Chang Gung Memorial Hospital between 2006 and 2018
• Availability of complete clinical, pathological, and follow-up data

You may not qualify if:

• Stage IV colon cancer at initial diagnosis
• Non-adenocarcinoma histology (e.g., undifferentiated carcinoma, squamous cell carcinoma, lymphoma, sarcoma)
• History of other malignancies or synchronous multiple cancers
• Patients who underwent only palliative surgery or local excision
• Incomplete medical records or missing follow-up information

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taoyuan, 33305, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 11, 2025
• Study Start: April 9, 2025
• Primary Completion: April 30, 2025
• Study Completion: August 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)