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CtDNA test guides chemo to stop rectal cancer return

NCT ID NCT07188025

Disease control Sponsor: Erasmus Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving chemotherapy after surgery can prevent rectal cancer from returning in people who have a positive ctDNA blood test (a sign of leftover cancer cells). About 103 adults with high-risk rectal cancer will either receive chemo or be observed. The goal is to see if chemo improves how long people stay cancer-free.

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 103 people

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

Started

Oct 2025

Expected to finish

Oct 2035

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 * Detectable ctDNA in the postoperative blood sample * Age ≥ 18 years * WHO performance score 0-1 * Informed consent for PLCRC with specific consent for additional blood withdrawals and offering of future experimental research * Informed consent for the REACT trial. * Histological confirmed rectal cancer; either treated with neoadjuvant (chemo)radiotherapy, and/or clinical/pathological T3/T4 and/or N+ in case no neoadjuvant therapy was administered. * Eligible to receive treatment with combination adjuvant chemotherapy (CAPOX/FOLFOX) according to the treating physician. * Mentally competent and able to read and understand Dutch language. Exclusion Criteria: * Metastatic disease * Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma * Incomplete primary tumour resection (R1 or R2 resection) * Contra-indication for fluoropyrimidines or oxaliplatin * Neoadjuvant oxaliplatin based systemic treatment, e.g. treated with the RAPIDO regimen consisting of short course radiotherapy followed by 6 cycles of CAPOX or 9 cycles of FOLFOX prior to surgery * Patients with a clinical complete response, who will not undergo surgery. * Pregnant and lactating women * History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance of the intervention group * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator * Serious infections (uncontrolled or requiring treatment) * Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another study interfering with the primary endpoint.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

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

Rectal cancer

How to take part

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

  1. The places running it

    25 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

  • Admiraal De Ruyter Ziekenhuis

    RECRUITING

    Goes, Netherlands

  • Albert Schweitzer Ziekenhuis

    RECRUITING

    Dordrecht, Netherlands

  • Amphia

    RECRUITING

    Breda, Netherlands

  • Amsterdam UMC

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Antonius Ziekenhuis Sneek

    NOT_YET_RECRUITING

    Sneek, Netherlands

  • Bernhoven

    NOT_YET_RECRUITING

    Uden, Netherlands

  • Bravis Ziekenhuis

    RECRUITING

    Roosendaal, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    NOT_YET_RECRUITING

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    NOT_YET_RECRUITING

    Eindhoven, Netherlands

  • Dijklander Ziekenhuis

    NOT_YET_RECRUITING

    Hoorn, Netherlands

  • Elisabeth-Tweesteden Ziekenhuis

    RECRUITING

    Tilburg, Netherlands

  • Erasmus MC

    RECRUITING

    Rotterdam, Netherlands

  • Franciscus

    RECRUITING

    Rotterdam, Netherlands

  • Frisius MC

    NOT_YET_RECRUITING

    Leeuwarden, Netherlands

  • Haaglanden Medisch Centrum

    NOT_YET_RECRUITING

    The Hague, Netherlands

  • Ikazia Ziekenhuis

    RECRUITING

    Rotterdam, Netherlands

  • Jeroen Bosch Ziekenhuis

    RECRUITING

    's-Hertogenbosch, Netherlands

  • Leids Universitair Medisch Centrum (LUMC)

    NOT_YET_RECRUITING

    Leiden, Netherlands

  • Maasstad Ziekenhuis

    RECRUITING

    Rotterdam, Netherlands

  • Martini Ziekenhuis

    RECRUITING

    Groningen, Netherlands

  • Meander Medisch Centrum

    RECRUITING

    Amersfoort, Netherlands

  • Radboud Universitair Medisch Centrum

    RECRUITING

    Nijmegen, Netherlands

  • Reinier de Graaf Ziekenhuis

    RECRUITING

    Delft, Netherlands

  • Ziekenhuisgroep Twente

    NOT_YET_RECRUITING

    Almelo, Netherlands

  • ZorgSaam

    RECRUITING

    Terneuzen, Netherlands

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