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Personalized chemotherapy dosing for patients with gastrointestinal cancers lacking a specific liver enzyme

Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers

Phase 2 Interventional Unicancer · NCT06475352

This study is testing if lowering the dose of a common chemotherapy drug can help people with gastrointestinal cancers who have a specific liver enzyme deficiency feel better while reducing side effects.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorUnicancer Academic / other
Drugs / interventionschemotherapy
Locations41 sites (Amiens and 40 other locations)
Trial IDNCT06475352 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to establish guidelines for reducing the dose of fluoropyrimidine in patients with DPD deficiency who are being treated for gastrointestinal cancers. It is a multicenter phase II trial that evaluates different strategies for adjusting fluoropyrimidine doses based on uracilemia levels. Participants will receive chemotherapy with a dose reduction as specified by the protocol and will attend regular clinic visits for monitoring and assessment of adverse events.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with gastrointestinal cancers who are starting chemotherapy and have been screened for DPD deficiency.

Not a fit: Patients who are not eligible for standard fluoropyrimidine and oxaliplatin doses or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective chemotherapy dosing for patients with DPD deficiency, minimizing adverse effects while maintaining treatment efficacy.

How similar studies have performed: Other studies have explored dose adjustments in chemotherapy based on genetic factors, showing promising results, but this specific approach for DPD deficiency is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Amiens and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Digestive CancerColorectal CancerFluoropyrimidineFOLFOXCAPOXAdjuvantMetastaticRecurrent
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.