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Tailored chemo doses aim to cut severe side effects in digestive cancer patients

NCT ID NCT06475352

Disease control Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adjusting chemotherapy doses based on a patient's DPD enzyme activity can reduce severe side effects in people with digestive cancers. About 400 participants with DPD deficiency will receive lower doses of fluoropyrimidine chemo (with oxaliplatin) and be monitored for toxicity. The goal is to find the safest effective dose for this group.

What this could mean

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

Active substance
fluoropyrimidine chemotherapy (5-fluorouracil or capecitabine) with oxaliplatin
What this could lead to
If successful, this could establish safer dosing guidelines for DPD-deficient patients, reducing severe side effects from standard chemotherapy.
What could go wrong
This is a Phase 2 trial with 400 participants, so results are still early. The dose adjustments may not work for all patients or cancer 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 400 people

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

Started

Jan 2025

Expected to finish

Jan 2030

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: 1. Patients with pre-treatment screening based on \[U\] value according to INCa/HAS recommendations. 2. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 3. Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplatin whatever the context (adjuvant, neoadjuvant, palliative) including the following regimens (the most frequently prescribed in gastrointestinal cancers): * biweekly 5-FU and oxaliplatin (FOLFOX) +/- targeted therapy (TT) * three-weekly capecitabine and oxaliplatin (CAPOX) +/- TT 4. Age ≥ 18 years 5. Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency 6. Adequate bone marrow function (cell blood count (CBC)), estimated glomerular filtration rate (DFG) ≥ 50 ml/min, alkaline phosphatase (ALP) / aspartate aminotransferase (ASAT) / alanine aminotransferase (ALAT) ≤ 5 upper limit of normal (ULN), and bilirubin ≤ 50 micromol/L 7. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. 8. Women of childbearing potential must have a negative serum or urine pregnancy test. 9. Patients must agree to remain abstinent or use contraceptive methods with a failure rate of \< 1% per year for the duration of study treatment and within 6 months after completing treatment. 10. Patients must be affiliated to a Social Security System (or equivalent). 11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up. Exclusion Criteria: 1. Patients with complete DPD deficiency based on \[U\] ≥150 ng/mL 2. Any prior treatment including a fluoropyrimidine 3. Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency 4. Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency 5. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial 6. Recent or concomitant treatment with brivudine 7. Pregnant or breastfeeding woman. 8. Participation in another therapeutic trial within 30 days prior to inclusion. 9. Persons deprived of their liberty or under protective custody or guardianship.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm digestive system cancer digestive system neoplasm neoplasm Neoplasm Metastasis Recurrence

As listed by the trial registrant

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

Colorectal cancer Digestive cancer

How to take part

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

  1. The places running it

    40 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

  • CH Aunay Bayeux

    RECRUITING

    Bayeux, 14400, France

  • CH Cote Basque

    RECRUITING

    Bayonne, 64109, France

  • CH de Saint Malo

    RECRUITING

    St-Malo, 35403, France

  • CHRU Nancy

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

  • CHU Amiens

    RECRUITING

    Amiens, 50054, France

  • CHU Besançon

    RECRUITING

    Besançon, 25000, France

  • CHU Bordeaux

    RECRUITING

    Pessac, 33600, France

  • CHU Clermont Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU Dijon

    RECRUITING

    Dijon, 21079, France

  • CHU Dupuytren

    RECRUITING

    Limoges, 87042, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86000, France

  • CHU Rouen - Hopital Charles Nicoles

    RECRUITING

    Rouen, France

  • CHU d'Orléans

    RECRUITING

    Orléans, 45067, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Eugene Marquis

    NOT_YET_RECRUITING

    Rennes, France

  • Centre François Baclesse

    RECRUITING

    Caen, 14000, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France

  • GH Diaconesses Croix St Simon

    RECRUITING

    Paris, 75020, France

  • GH Mutualiste de Grenoble

    RECRUITING

    Grenoble, 38028, France

  • Grand Hopital de l'Est Francilien

    RECRUITING

    Meaux, 77100, France

  • Gustave Roussy Cancer Campus

    RECRUITING

    Villejuif, 94805, France

  • Hopital Beaujon

    RECRUITING

    Clichy, 92110, France

  • Hopital Bretonneau

    RECRUITING

    Tours, 37044, France

  • Hopital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • Hopital Henri Mondor

    RECRUITING

    Aurillac, France

  • Hopital Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • Hopital Nord Franche Comté - Site du Mittan

    RECRUITING

    Montbéliard, 25200, France

  • Hopital Privé Drome-Ardeche

    RECRUITING

    Guilherand-Granges, 07500, France

  • Hopital Privé Jean Mermoz

    RECRUITING

    Lyon, 69008, France

  • Hopital Robert Debré

    RECRUITING

    Reims, 51100, France

  • Hopital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Hopital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hospices Civiles de Lyon

    RECRUITING

    Pierre-Bénite, 69495, France

  • Infirmerie Protestante

    NOT_YET_RECRUITING

    Caluire-et-Cuire, France

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Jean Godinot

    WITHDRAWN

    Reims, 51100, France

  • Institut du Cancer Avignon Provence

    RECRUITING

    Avignon, 84000, France

  • Institut du Cancer de Strasbourg

    RECRUITING

    Strasbourg, 67033, France

  • Polyclinique du Parc - Centre d'Oncologie Maurice Tubiana

    RECRUITING

    Caen, 14000, France

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