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Blood test could personalize chemo breaks for advanced colon cancer

NCT ID NCT06446557

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a blood test that measures tumor DNA (ctDNA) can help doctors decide when to reduce or switch chemotherapy in people with metastatic colorectal cancer. About 408 participants will be randomly assigned to either standard treatment or a strategy where ctDNA levels guide whether they stop chemo, continue with a milder maintenance, or switch drugs. The goal is to see if the ctDNA-guided approach improves survival while maintaining quality of life.

What this could mean

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

Active substance
chemotherapy plus targeted agent (anti-EGFR or bevacizumab)
What this could lead to
If successful, this could show that using a simple blood test to guide treatment decisions improves survival and quality of life for people with metastatic colorectal cancer.
What could go wrong
This is a large phase 3 trial, but it only includes a specific subset of patients (left-sided, MSS, BRAF wild-type). The ctDNA test may not work as expected, and the experimental strategy could be no better or even worse than standard care.

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 408 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2032

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: * Histologically proven diagnosis of RAS WT or mutant, MSS, BRAFV600E non-mutated colorectal cancer. * Left side or rectal cancer * An unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease. * At least one measurable lesion according to RECIST criteria version 1.1. * Age ≥ 18 years. * ECOG PS ≤ 1 * Neutrophils ≥ 1.5 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, Hb \> 9 g/dl. * Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases. * Creatinine clearance \> 50 mL/min or serum creatinine ≤ 1.5 x UNL. * The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. * Adequate coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial. Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x ULN. * Written informed consent. Exclusion Criteria: * Right side colon cancer * First-line chemotherapy +/- biologic agents for mCRC before C1 * Radiotherapy to any site within 4 weeks before C1 * Adjuvant oxaliplatin-based treatment completed less than 6 months before relapse. * Treatment with any investigational drug within 30 days prior to C1 * Known allergy to any of the study treatment components. * Dihydropyrimidine dehydrogenase (DPD) deficiency. * Documented and/or symptomatic brain or leptomeningeal metastases. * Patient with active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator. * Uncontrolled or poorly controlled hypertension despite standard medical management. * Severe renal or hepatic failure * Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to C1 * Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start. * Infection with the human immunodeficiency virus. * Symptomatic peripheral neuropathy grade 1 according the NCI CTC. * Acute or subacute bowel obstruction or history of chronic diarrhea, which is considered clinically significant in the opinion of the investigator. * Chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted. * Pregnant or lactating women. * Patient with active psychiatric illness or social situation that would severely limit compliance with study requirements.

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • CHU de ROUEN

    Rouen, 76031, France

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