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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Amiens
  Amiens, France Recruiting
• Hopital Henri Mondor
  Aurillac, France Recruiting
• Institut du Cancer Avignon Provence
  Avignon, France Recruiting
• CH Aunay Bayeux
  Bayeux, France Recruiting
• CH Cote Basque
  Bayonne, France Recruiting
• CHU Besançon
  Besançon, France Recruiting

Study contacts

• Principal investigator: Valérie BOIGE, MD — Gustave Roussy Cancer Campus
• Study coordinator: Nicolas DE SOUSA CARVALHO
• Email: n-de-sousa@unicancer.fr
• Phone: 01 71 93 67 09

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.