Colon CancerSTARSNCT07167147
Survival Outcomes by Tumor-Node Stage and Recurrence Patterns in Colon Cancer After Radical Surgery
An observational study of Colon Cancer and Colon Adenocarcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Adenocarcinoma, Colon Cancer Stage III
- How many people
- 7,259 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Apr 2025to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
Colon cancer remains a major cause of cancer-related morbidity and mortality worldwide. Even after curative resection, recurrence occurs in a significant proportion of patients, and survival outcomes vary depending on tumor and nodal status at diagnosis. While the TNM staging system is widely used for prognosis, the specific association between tumor-node (TN) combinations and recurrence patterns, as well as their impact on survival, is not fully established.
The objective of this study is to investigate the relationship between TN stage and recurrence patterns in patients with stage I-III colon adenocarcinoma who underwent radical surgery at Chang Gung Memorial Hospital, Taiwan. A retrospective cohort of 7,259 patients who had surgery between 2006 and 2018 is analyzed using data from the institutional tumor registry. Patients are categorized into four groups according to T and N status: T1-3N0, T1-3N+, T4N0, and T4N+.
Primary outcomes include recurrence patterns (local recurrence, isolated lung metastasis, isolated liver metastasis, multiple-site metastases, or no recurrence). The secondary outcome is overall survival, assessed both after surgery and after recurrence. Planned statistical analyses include multinomial logistic regression to evaluate recurrence risk by TN stage, Kaplan-Meier survival curves with log-rank tests to compare survival across recurrence types, and marginal structural models with inverse probability weighting to address time-dependent confounders and estimate causal effects of TN stage and recurrence on mortality risk.
This retrospective analysis was reviewed and approved by the Institutional Review Board of Chang Gung Memorial Hospital (IRB No: 202500389B0). Patient consent was waived because only de-identified registry data are used.
- Conditions
- Colon Cancer, Colon Adenocarcinoma, Colon Cancer Stage III, Colon Cancer Stage I, Colon Cancer Stage II, Cancer Recurrence
- 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
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From date of radical surgery until death from any cause, assessed up to 5 years.
Secondary outcomes (4)
Disease-Free Survival
Time from surgery to first documented recurrence (local or distant) or death from any cause, whichever occurs first.
Measured: 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)
Time from surgery to death specifically attributable to colon cancer, assessed through clinical records and registry data.
Measured: From date of radical surgery until death specifically attributable to colon cancer, assessed up to 5 years.
All-Cause Mortality by Recurrence Pattern
Mortality rates stratified by first recurrence type (local, isolated lung, isolated liver, multiple sites).
Measured: From date of first documented recurrence until death from any cause, assessed up to 5 years.
Prognostic Impact of Tumor-Node Stage
Association between TN stage at diagnosis (T1-3N-, T1-3N+, T4N-, T4N+) and recurrence/metastasis risk, measured by multinomial regression models.
Measured: From date of diagnosis and radical surgery until the date of first documented recurrence or metastasis, assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Apr 2025
- Primary completion30 Apr 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167147
- Sponsor's protocol ID
- 202500389B0
- Acronym
- STARS
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical considerations. Only aggregated study results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcomes by Tumor-Node Stage and Recurrence Patterns in Colon Cancer After Radical Surgery
- ClinicalTrials.gov ID
- NCT07167147
- Acronym / sponsor ID
- STARS / 202500389B0
- Conditions
- Colon Cancer, Colon Adenocarcinoma, Colon Cancer Stage III, Colon Cancer Stage I, Colon Cancer Stage II, Cancer Recurrence
- Keywords
- Colon Cancer, Colon Adenocarcinoma, Stage I-III Colon Cancer, Tumor-Node Stage, TN Staging, Cancer Recurrence, Recurrence Patterns, Survival Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,259 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Colon cancer remains a major cause of cancer-related morbidity and mortality worldwide. Even after curative resection, recurrence occurs in a significant proportion of patients, and survival outcomes vary depending on tumor and nodal status at diagnosis. While the TNM staging system is widely used for prognosis, the specific association between tumor-node (TN) combinations and recurrence patterns, as well as their impact on survival, is not fully established.
The objective of this study is to investigate the relationship between TN stage and recurrence patterns in patients with stage I-III colon adenocarcinoma who underwent radical surgery at Chang Gung Memorial Hospital, Taiwan. A retrospective cohort of 7,259 patients who had surgery between 2006 and 2018 is analyzed using data from the institutional tumor registry. Patients are categorized into four groups according to T and N status: T1-3N0, T1-3N+, T4N0, and T4N+.
Primary outcomes include recurrence patterns (local recurrence, isolated lung metastasis, isolated liver metastasis, multiple-site metastases, or no recurrence). The secondary outcome is overall survival, assessed both after surgery and after recurrence. Planned statistical analyses include multinomial logistic regression to evaluate recurrence risk by TN stage, Kaplan-Meier survival curves with log-rank tests to compare survival across recurrence types, and marginal structural models with inverse probability weighting to address time-dependent confounders and estimate causal effects of TN stage and recurrence on mortality risk.
This retrospective analysis was reviewed and approved by the Institutional Review Board of Chang Gung Memorial Hospital (IRB No: 202500389B0). Patient consent was waived because only de-identified registry data are used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence Patterns After Radical Surgery in Stage I-III Colon Cancer
Time frame: From date of radical surgery until the date of first documented recurrence, assessed up to 60 months.
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.
Overall Survival After Radical Surgery in Stage I-III Colon Cancer
Time frame: From date of radical surgery until death from any cause, assessed up to 5 years.
Defined as the time from surgery to death from any cause, assessed using hospital records and national death registry data.
4 secondary outcomes
Disease-Free Survival
Time frame: 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)
Time frame: From date of radical surgery until death specifically attributable to colon cancer, assessed up to 5 years.
All-Cause Mortality by Recurrence Pattern
Time frame: From date of first documented recurrence until death from any cause, assessed up to 5 years.
Prognostic Impact of Tumor-Node Stage
Time frame: From date of diagnosis and radical surgery until the date of first documented recurrence or metastasis, assessed up to 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical considerations. Only aggregated study results will be published in peer-reviewed journals.
Related trials for Colon Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colon Adenocarcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Patterns After Radical Surgery in Stage I-III Colon Cancer (time frame: From date of radical surgery until the date of first documented recurrence, assessed up to 60 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.