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New trial aims to boost colon cancer treatment by giving chemo before surgery

NCT ID NCT06107920

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether giving chemotherapy before surgery (neoadjuvant) helps patients with obstructive colon cancer complete their full treatment plan. About 232 adults with stable microsatellite tumors will be randomly assigned to standard care or the new sequence. The goal is to see if more patients can finish all planned chemo and surgery, potentially improving outcomes.

What this could mean

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

Active substance
chemotherapy (drugs given before surgery)
What this could lead to
If successful, this approach could help more patients with blocked colon cancer receive full treatment, potentially improving survival and reducing recurrence.
What could go wrong
This is a Phase 3 trial, but results are not yet known. Chemotherapy before surgery may cause side effects, and not all patients may benefit. The study is limited to specific tumor types.

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 232 people

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

Started

May 2024

Expected to finish

Aug 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 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: * Age ≥ 18 years * ECOG performance status 0 or 1 * Patients with obstructive colon cancer treated by defunctioning stoma * Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge- left transverse colon) - MSS/pMMR (microsatellites stable primary tumor) status * Patient requiring colectomy * Laboratory data including : White blood cell count ≥ 3.109 /L with Neutrophils ≥ 1,5.109 / L, Platelet count ≥ 100.109 / L, Hemoglobin ≥ 9 g/dL (5,6 mmol/L), Total bilirubin ≤ 1,5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2,5 x ULN, Alkaline phosphatase ≤ 1,5 x ULN, Serum creatinine ≤ 1,5 x ULN (performed 10-15 days prior to randomization). * Non metastatic colon cancer (lung, liver, peritoneal) on thoracic-abdomino-pelvis CT scan * Absence of synchronous colorectal cancer * No prior chemotherapy or abdominal or pelvic irradiation * No history of colorectal cancer * No serious medical co-morbidity : uncontrolled inflammatory bowel disease, uncontrolled angina, recent \[within the past 6 months\] myocardial infarction, or another serious medical condition, judged to compromise ability to tolerate chemotherapy and/or surgery * Women of childbearing potential with effective contraception will be required during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment and a negative blood pregnancy test by beta-HCG at inclusion. * Women surgically sterile (absence of ovaries and/or uterus) * Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) * For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment. * Patient able to comply with the study protocol, in the investigator's judgment * Patient affiliated with, or beneficiary of a social security (national health insurance) category * Person informed and having signed his consent Exclusion Criteria: * Contraindication to colectomy and/or anesthesia * Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery * Patient having received radiation therapy prior to surgery * Metastatic spread at baseline assessment (lung, liver, peritoneal) * History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1 * Contraindication to study neoadjuvant chemotherapy treatments * Presence of inflammatory bowel disease, HNPCC syndrome or polyposis Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, or high risk of uncontrolled arrhythmia * Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency) * 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. * Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 6 months after the treatment termination * Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision) * Simultaneous participation in another interventional research

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aphm Hopital Nord

    RECRUITING

    Marseille, 13015, France

  • Aphm La Timone

    RECRUITING

    Marseille, 13005, France

  • Aphp Antoine Beclere

    RECRUITING

    Clamart, 92140, France

  • Aphp Avicenne

    RECRUITING

    Bobigny, 93000, France

  • Aphp Cochin

    RECRUITING

    Paris, 75014, France

  • Aphp Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • Aphp Kremlin Bicetre

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • Aphp Saint Antoine

    RECRUITING

    Paris, 75012, France

  • CHU CAEN

    RECRUITING

    Caen, 14000, France

  • CHU LYON

    RECRUITING

    Pierre-Bénite, 69495, France

  • Ch Poissy

    RECRUITING

    Poissy, 78303, France

  • Ch St Denis

    RECRUITING

    Saint-Denis, 93200, France

  • Ch Versailles

    RECRUITING

    Versailles, 78150, France

  • Chr Beauvais

    RECRUITING

    Beauvais, 60021, France

  • Chru Besancon

    RECRUITING

    Besançon, 25030, France

  • Chru Lille

    RECRUITING

    Lille, 59037, France

  • Chru Lille

    RECRUITING

    Lille, 59037, France

  • Chru Nancy

    RECRUITING

    Nancy, 54511, France

  • Chu Amiens

    RECRUITING

    Amiens, 80054, France

  • Chu Colmar

    RECRUITING

    Colmar, 68024, France

  • Chu Dijon

    RECRUITING

    Dijon, 21079, France

  • Chu Grenoble

    RECRUITING

    Grenoble, 38043, France

  • Chu Limoges

    RECRUITING

    Limoges, 87042, France

  • Chu Nantes

    RECRUITING

    Nantes, 44093, France

  • Chu Rouen

    RECRUITING

    Rouen, 76031, France

  • Chu Strasbourg

    RECRUITING

    Strasbourg, 67200, France

  • Chu Tours

    RECRUITING

    Tours, 37170, France

  • Gh Diaconesses Croix St Simon

    RECRUITING

    Paris, 75960, France

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