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Dose individualization of chemotherapy in patients with gastrointestinal cancers lacking a specific liver enzyme
EU CTIS ID: 2023-509963-25-00
What this study is testing
To assess different strategies of FP-dose adjustment according to [U] in DPD-deficient patients in terms of early severe FP-induced toxicity (i.e. during the first 2 cycles of FOLFOX or CAPOX-based regimens) in order to generate guidelines for dose reduction in patients with DPD deficiency
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with pre-treatment screening based on [U] value according to INCa/HAS recommendations.
- Women of childbearing potential must have a negative serum or urine pregnancy test.
- 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.
- Patients must be affiliated to a Social Security System (or equivalent).
- 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.
- ECOG PS ≤2
You likely can't join if
- Patients with complete DPD deficiency based on [U] ≥150 ng/mL
- Any peripheral sensitive neuropathy with functional impairment
- Any prior treatment including a FP
- Patients with any contraindication to treatment with FP or oxaliplatin regardless of DPD deficiency
- Patients not eligible for full standard dose FP 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
See the full eligibility criteria
- Patients with pre-treatment screening based on [U] value according to INCa/HAS recommendations.
- Women of childbearing potential must have a negative serum or urine pregnancy test.
- 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.
- Patients must be affiliated to a Social Security System (or equivalent).
- 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.
- ECOG PS ≤2
- FP-naïve patients with GI cancer starting chemotherapy combining FP (5FU or capecitabine) and oxaliplatin whatever the context (adjuvant, neoadjuvant, palliative) including the following regimens (the most frequently prescribed in GI cancers): - biweekly 5-FU and oxaliplatin (FOLFOX) +/- targeted therapy (TT) - three-weekly capecitabine and oxaliplatin (CAPOX) +/- TT
- Age ≥ 18 years
- Patients eligible for full standard FP and oxaliplatin doses regardless of DPD deficiency
- Adequate bone marrow function (cell blood count (CBC)), estimated glomerular filtration rate (DFG) ≥ 60 ml/min, ALP/ASAT/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.
- Patients with complete DPD deficiency based on [U] ≥150 ng/mL
- Any peripheral sensitive neuropathy with functional impairment
- Any prior treatment including a FP
- Patients with any contraindication to treatment with FP or oxaliplatin regardless of DPD deficiency
- Patients not eligible for full standard dose FP 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.
- Persons deprived of their liberty or under protective custody or guardianship.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.