Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specif… (NCT06475352) | Clinical Trial Compass
RecruitingPhase 2
Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
France400 participantsStarted 2025-01-20
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with pre-treatment screening based on \[U\] value according to INCa/HAS recommendations.
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2
✓. 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):
✓. Age ≥ 18 years
✓. Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency
✓. 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
✓. 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.
✓. Women of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion criteria
✕. Patients with complete DPD deficiency based on \[U\] ≥150 ng/mL
✕. Any prior treatment including a fluoropyrimidine
What they're measuring
1
Proportion of fluoropyrimidine-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles
Timeframe: Throughout the two first cycles of treatment, up to 42 days
✕. Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency
✕. Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency
✕. 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
✕. Recent or concomitant treatment with brivudine
✕. Pregnant or breastfeeding woman.
✕. Participation in another therapeutic trial within 30 days prior to inclusion.