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Colon cancer study aims to improve treatment for older patients

NCT ID NCT04416490

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows over 2,000 Korean patients with stage II or III colon cancer after surgery to see which chemotherapy treatments they actually receive and how they fare. Unlike typical clinical trials, it includes older adults and reflects real-world medical practice. The goal is to gather data that could lead to better, more personalized treatment guidelines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors tailor chemotherapy after colon cancer surgery, especially for older patients who are often left out of clinical trials.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new drug or cure. Results may not apply outside of Korea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,013 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with high-risk stage II or stage III primary colon cancer who have received curative resection. Approximately 2,000 subjects.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects are given explanations about the study objectives and methods, and will express their consent by signing a written agreement to use their personal information. 2. Male and female adult subjects who are ≥ 19 years old. 3. Subjects are confirmed to have primary colon cancer through histological diagnosis and are at \*high-risk stage II (T3/4, N0M0) or stage III (any T, N1/2, M0). * High-risk stage II is determined when one or more of the following are applicable. 1. Cancer is at T4 stage (stage IIB,IIC); 2. Cancer cell differentiation grade is 3 or 4 (poor histologic grade); 3. Cancer cells are present in lymphatic or blood vessels around the tumor (peritumoral lymphovascular involvement); 4. Ileus was present during surgery (bowel obstruction at presentation); 5. Cancer is at T3 stage with localized perforation or there are indeterminate cancer cells residual on the incisal surface. (T3 lesions with localized perforation or close, indeterminate, or positive margins); or, 6. Cancer cells invaded into the area around the ganglion (perineural invasion). 4. Subjects are decided to require adjuvant chemotherapy including oxaliplatin and/or capecitabine after curative resection (E.g.: FOLFOX, CapeOx or Capecitabine and modified therapies). 5. Subjects' performance status score (ECOG PS) is 2 or lower (0, 1, 2). Exclusion Criteria: 1. Subjects are diagnosed with other primary cancers that can influence the treatment or prognosis of primary rectal and colon cancers. 2. Subjects are diagnosed with relapsed or secondary colon cancer. 3. Subjects with Stage 0/1 (Tis/1/2, N0M0) or Stage IV (any T, any N, M1) colon cancer. 4. Subjects who are currently on adjuvant chemotherapy after curative resection. 5. Subjects who are receiving palliative chemotherapy. 6. Pregnant and breast-feeding subjects. 7. Subjects who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the duration of this study. However, subjects participating in a noninterventional observational study or a registry study can participate in this study. 8. Other subjects who are not suitable for study participation upon the investigator's decision.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yonsei University Health System, Severance Hospital

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.