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Could chemo before surgery spare colon cancer patients from extra cycles?

NCT ID NCT01918527

Disease control Sponsor: Vejle Hospital Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 1 time

Summary

This study compares giving 3 rounds of chemotherapy before surgery versus the standard approach of surgery followed by 8 rounds of chemo for people with locally advanced colon cancer. The goal is to see if the pre-surgery chemo works just as well and may allow some patients to skip up to 5 rounds of post-surgery chemo. About 250 adults with T3 or T4 colon cancer are taking part.

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

250 people

The number who actually took part.

Started

Sep 2013

Finished

Jun 2026

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 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: * Histologically verified locally advanced T3 (ETI \> 5 mm) or T4 colon cancer assessed by CT scan. * Age ≥ 18 years * PS 0-2. * Hematology ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l. * Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value * Consent to translational research * Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. * Written and orally informed consent. Exclusion Criteria: * Patients with distant metastases. * Acute operation * Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion. * Active, serious infection or other serious disease. * Peripheral neuropathy NCI grade \> 1 * Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri. * Other investigational treatment within 30 days prior to treatment start. * Hypersensitivity to one or more of the active or auxiliary substances.

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm

As listed by the trial registrant

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

Colon cancer

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, Denmark

  • Haukeland University Hospital

    Bergen, Norway

  • Herlev Hospital

    Herlev, Denmark

  • Hilleroed Hospital

    Hillerød, Denmark

  • Rigshospitalet

    Copenhagen, Denmark

  • Roskilde Hospital

    Roskilde, Denmark

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Sygehus Sønderjylland

    Sønderborg, Denmark

  • Vejle Hospital

    Vejle, Denmark

More trials for these conditions

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