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Could chemo before surgery stop colon cancer from coming back?

NCT ID NCT03426904

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving chemotherapy before surgery (instead of after) helps people with locally advanced colon cancer live longer without the cancer returning. About 708 adults aged 18 to 70 with non-spreading colon cancer are taking part. The goal is to see if early chemo can kill hidden cancer cells and reduce the chance of recurrence.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 708 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 years

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: * Pathologically confirmed colon adenocarcinoma (\> 15 cm from the anal verge) * Radiologic T3/T4 and high risk features by CT scan * No metastasis on CT or PET(positron emission computed tomography) * Age ≥ 18 and ≤ 70 years * ECOG (Eastern Cooperative Oncology Group) performance status 0-1 * No history of colorectal cancer within 5 years * No history of chemotherapy * Patients with childbearing potential should use effective contraception during the study and the following 6 months * Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more * Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less * Adequate renal function : GFR (Glomerular Filtration Rate) \> 50ml/min by Wright or Cockcroft formula * Signed written informed consent obtained prior to any study specific screening procedures Exclusion Criteria: * Age \> 70 years and \< 18 years * Rectal cancer : 15 cm or less from the anal verge * Complicated colon cancer (complete obstruction, perforation, bleeding) * Metastatic colon cancer * Known hypersensitivity reaction to any of the components of study treatments * Inflammatory bowel disease * Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis * Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia * Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Pregnancy or breast-feeding period * Serious non-healing wound or bone fracture * Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent * Any significant disease which, in the investigator's opinion, would exclude the patient from the study

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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

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Chonnam National University Hwasun Hospital

    Hwasun, Chonnam, 58128, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • The Catholic Univ. of Korea St. Vincent's Hospital

    Suwon, South Korea

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