CAPECITABINE for Gastrointestinal cancer | Colon cancer | Colorectal cancer

Inclusion criteria

• {"criterion_text":"- Patients with pre-treatment screening based on [U] value according to INCa/HAS recommendations."}
• {"criterion_text":"- Women of childbearing potential must have a negative serum or urine pregnancy test."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients must be affiliated to a Social Security System (or equivalent)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- ECOG PS ≤2"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Patients eligible for full standard FP and oxaliplatin doses regardless of DPD deficiency"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Patients with complete DPD deficiency based on [U] ≥150 ng/mL"}
• {"criterion_text":"- Any prior treatment including a FP"}
• {"criterion_text":"- Patients with any contraindication to treatment with FP or oxaliplatin regardless of DPD deficiency"}
• {"criterion_text":"- Patients not eligible for full standard dose FP and oxaliplatin for clinical reasons including older age and/or comorbidity regardless of a DPD deficiency"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Recent or concomitant treatment with brivudine"}
• {"criterion_text":"- Pregnant or breastfeeding woman."}
• {"criterion_text":"- Participation in another therapeutic trial within 30 days prior to inclusion."}
• {"criterion_text":"- Persons deprived of their liberty or under protective custody or guardianship."}
• {"criterion_text":"- Any peripheral sensitive neuropathy with functional impairment"}

Primary endpoints

• {"endpoint_text":"- Proportion of FP-induced grade ≥ 3 haematological and gastrointestinal toxicity after 2 cycles (4 weeks for FOLFOX +/- TT or 6 weeks for 2 CAPOX +/- TT) according to the National Cancer Institute - common terminology criteria for adverse events (NCI CTCAE) version 5.0 in patients treated for a GI cancer in the (neo-)adjuvant or the metastatic setting.","definition_or_measurement_approach":"Measured as the proportion of patients with FP-induced grade ≥3 haematological and gastrointestinal toxicities assessed using NCI CTCAE v5.0 after 2 cycles (4 weeks for FOLFOX regimens; 6 weeks for 2 CAPOX cycles)."}

Secondary endpoints

• {"endpoint_text":"- The recommended FP dose will be estimated by comparing the rate of FP-induced grade ≥ 3 haematological and gastrointestinal toxicity in each [U]-based group of DPD-deficient patients (according to [U] level) to the one observed in non DPD-deficient patients (control arm) during the first 4 cycles of chemotherapy","definition_or_measurement_approach":"Comparison of rates of FP-induced grade ≥3 haematological and gastrointestinal toxicity between [U]-based DPD-deficient groups and non DPD-deficient control arm during the first 4 cycles."}
• {"endpoint_text":"- Description of FP doses administered during the first 4 chemotherapy cycles in all patients, along with reasons of dose-modifications or treatment discontinuation for limiting toxicity","definition_or_measurement_approach":"Record FP doses administered during cycles 1–4 and capture reasons for dose-modification or discontinuation attributable to limiting toxicity."}
• {"endpoint_text":"- Percentage of patients in whom FP dose is increased or decreased during the first 4 cycles of chemotherapy","definition_or_measurement_approach":"Proportion of patients with any FP dose escalation or reduction during cycles 1–4."}
• {"endpoint_text":"- All grade FP-induced toxicities at each cycle 1 to 4, related (neutropenia, febrile neutropenia, anemia, thrombocytopenia, diarrhea, mucositis) or not including (hand-foot syndrome, central neurotoxicity, cardiotoxicity) to DPD-deficiency (NCI CTC-AE). All other FP induced toxicity related or not will be also described.","definition_or_measurement_approach":"All-grade FP-induced toxicities captured per cycle 1–4 and graded per NCI CTCAE (includes specified events)."}
• {"endpoint_text":"- Treatment efficacy will be evaluate in terms of: o DFS defined as the time from surgery to disease recurrence (radiological or clinical) in the subgroup of patients with stage III colon cancer and especially the 3-year DFS.","definition_or_measurement_approach":"DFS measured from surgery to radiological or clinical recurrence; 3-year DFS specifically reported for stage III colon cancer subgroup."}
• {"endpoint_text":"- Treatment efficacy will be evaluate in terms of: o OS defined as the time from surgery until death from any cause in the subgroup of patients with stage III colon cancer","definition_or_measurement_approach":"Overall survival measured from surgery to death from any cause in the stage III colon cancer subgroup."}
• {"endpoint_text":"- Treatment efficacy will be evaluate in terms of: o PFS defined as the time from inclusion to disease progression (radiological or clinical) or death of any cause, whichever occurs first, in the subgroup of patients with stage IV colorectal cancer","definition_or_measurement_approach":"Progression-free survival measured from inclusion to radiological/clinical progression or death, whichever first, in stage IV colorectal cancer subgroup."}

France

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

470

Number Of Sites

43

Number Of Participants

400

Primary sponsor

Full Name

Unicancer

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France