A Phase 2 interventional study of FOLFOX regimen and CAPOX regimen in Digestive Cancer and Colorectal Cancer, sponsored by UNICANCER. Recruiting at 41 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by UNICANCER · Phase 2, Interventional, and Treatment
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:
Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to [U] in DPD-deficient patients with gastrointestinal cancer.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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):
Exclusion Criteria:
Patient with uracilemia \<16 ng/mL will receive a full standard fluoropyrimidine dose
Drug: FOLFOX regimen · Drug: CAPOX regimen
Patients with uracilemia between \[16-20\[ ng/mL will receive a full standard fluoropyrimidine dose -dose
Drug: FOLFOX regimen · Drug: CAPOX regimen
Patients with uracilemia between \[20-50\[ ng/mL will be randomized to receive a 25% fluoropyrimidine dose reduction
Drug: FOLFOX regimen · Drug: CAPOX regimen
Patients with uracilemia between \[20-50\[ ng/mL will be randomized to receive a 50% fluoropyrimidine dose reduction
Drug: FOLFOX regimen · Drug: CAPOX regimen
Patients with uracilemia between \[50-100\[ ng/mL will receive a 50% fluoropyrimidine dose reduction
Drug: FOLFOX regimen · Drug: CAPOX regimen
Patients with uracilemia between \[100-150\[ ng/mL will receive a 75% fluoropyrimidine dose reduction
Drug: FOLFOX regimen · Drug: CAPOX regimen
Oxaliplatin will be administered at a fixed dose of 85 mg/m² by 2h intravenous (IV) infusion concurrently with folinic acid 400 mg/m² (or 200 mg/m² if L-folinic acid) as a 2 h IV infusion on day 1 of each 14-day cycle followed by 5-fluorouracil (5-FU) 400 mg/m² IV bolus on day 1, then continuous IV infusion of 1,200 mg/m² /day × 2 days (total 2400 mg/m² for 46-48 hours)
Oxaliplatin will be administered at a fixed dose of 130 mg/m² by 2h IV infusion on day 1 of each 21-day cycle followed by capecitabine (1000 mg/m²) twice a day (BID) during 2 weeks, every 3 weeks
Proportion of fluoropyrimidine-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Time frame: Throughout the two first cycles of treatment, up to 42 days
Recommended fluoropyrimidine dose
The rate of fluoropyrimidine induced grade ≥ 3 haematological and gastrointestinal toxicity in each uracilemia-based group of DPD-deficient patients (according to uracilemia level) compared to the rate observed in non DPD-deficient patients (control arm)
Time frame: Throughout the four first cycles of treatment, up to 3 months
Description of fluoropyrimidine dose
The cumulative dose (mg/m²) of chemotherapy delivered to patients will be recorded along with reasons of dose-modifications or treatment discontinuation for limiting toxicity
Time frame: Throughout the four first cycles of treatment, up to 3 months
Percentage of fluoropyrimidine dose modification
Percentage of patients for whom fluoropyrimidine dose is increased or decreased
Time frame: Throughout the four first cycles of treatment, up to 3 months
Fluoropyrimidine toxicity during the study
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Time frame: Throughout the four first cycles of treatment, up to 3 months
Disease-free survival (DFS) - Stage III Colon Cancer
Disease-free survival is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Time frame: 3 years
Overall survival (OS) - Stage III Colon Cancer
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Time frame: From randomization to death from any cause, up to 3 years.
Progression-free survival (PFS) - Stage IV Colon Cancer
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Time frame: From randomization to disease progression or death, up to 1 year.
Plan to share: No — Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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