NCT06475352 Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
| NCT ID | NCT06475352 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | UNICANCER |
| Condition | Digestive Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2025-01-20 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers. The main question it aims to answer is: \- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency? Participants will: * Take the treatment with the reduction of dose stated by the protocol * Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events
Eligibility 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.
Contact & Investigator
Valérie BOIGE, MD
PRINCIPAL INVESTIGATOR
Gustave Roussy Cancer Campus
Frequently Asked Questions
Who can join the NCT06475352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Digestive Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06475352 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06475352 currently recruiting?
Yes, NCT06475352 is actively recruiting participants. Contact the research team at n-de-sousa@unicancer.fr for enrollment information.
Where is the NCT06475352 trial being conducted?
This trial is being conducted at Amiens, France, Aurillac, France, Avignon, France, Bayeux, France and 11 additional locations.
Who is sponsoring the NCT06475352 clinical trial?
NCT06475352 is sponsored by UNICANCER. The principal investigator is Valérie BOIGE, MD at Gustave Roussy Cancer Campus. The trial plans to enroll 400 participants.
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