2023-507873-16-00Not yet recruitingPhase III and phase IV (Integrated)
Chimiothérapie à base de bevacizumab adaptée à la pharmacocinétique du bevacizumab en 1ère ligne de traitement du cancer colorectal métastatique non résécable : étude de phase 3 randomisée multicentrique en double aveugle.
Centre Hospitalier Regional Universitaire De Tours19 sites in 1 country122 target enrollmentStarted: August 19, 2024Last updated:
Trial Snapshot
- Phase
- Phase III and phase IV (Integrated)
- Status
- Not yet recruiting
- Enrollment
- 122
- Locations
- 19
- Primary Endpoint
- The primary endpoint is progression-free survival (PFS)
Study Overview
Brief Summary
The primary objective is to evaluate the effect of doubling the dose of bevacizumab in patients with mCRC treated in 1st line with a bevacizumab-based chemotherapy regimen whose trough serum concentration of bevacizumab is ≤ 15.5 mg /L on day 14 of the first administration of bevacizumab on progression-free survival (PFS).
Study Design
- Allocation
- Randomized
- Primary Purpose
- Suivi
- Masking
- Double (Subject, Monitor, Investigator, Analyst)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients ≥18 years old
- •Signature of free, written and informed consent by the patient;
- •Affiliation to a French social security system.
- •Randomization criteria in the experimental phase: - 1st residual serum concentration (Cres) of bevacizumab ≤ 15.5 mg/L measured just before the 2nd infusion of bevacizumab (D14).
- •ECOG Performance status (PS) 0-2
- •Having a histologically proven metastatic colorectal adenocarcinoma (on primary tumor and/or metastases) that is inoperable and well documented, i.e. not compatible with complete oncological resection at inclusion
- •For whom treatment with bevacizumab is indicated
- •For women of childbearing age: effective contraception
- •No prior treatment with palliative chemotherapy for metastatic disease (in case of adjuvant treatment, interval between the end of chemotherapy and relapse > 6 months)
- •At least one evaluable or measurable lesion assessed by computed tomography (CT) according to RECIST v1.1 criteria
- •Estimated life expectancy greater than 3 months
- •Adequate hematological, renal and hepatic biological parameters: . Neutrophils ≥ 1.5x109/L; . Platelets ≥ 100x109/L; . Hemoglobin ≥ 9 g/dL; . Serum creatinine <150 μmol/L; . Bilirubinemia ≤ 1.5 x upper limit of normal (ULN), . Alkaline phosphatase < 5xULN; . Proteinuria < 2+ (urine strip) or ≤ 1 g/24h
Exclusion Criteria
- •Patient with a known contraindication to first-line chemotherapy based on bevacizumab
- •Patient under guardianship, curatorship or safeguard of justice.
- •Inadequate hematological, hepatic or renal function
- •Contraindication to bevacizumab (major surgery within 28 days, risk of arterial thrombosis, risk of bleeding, deep vein thrombosis without effective anticoagulant treatment or unbalanced anticoagulant treatment)
- •In the event of brain metastases, their treatment (surgery and/or radiotherapy) must have been completed more than 4 weeks before the first cycle of chemotherapy under study
- •Serious non-healing wound, active ulcer or untreated bone fracture: ° Other neoplasia (recent or current history), except carcinoma in situ of the cervix treated adequately, localized basal cell or squamous cell carcinoma of the skin managed with curative intent ° Neoplasia in complete remission for more than 5 years.
- •Other illness, which, according to the doctor, is life-threatening to the patient and/or which is uncontrolled
- •Primary tumor present and symptomatic (occlusion, hemorrhage)
- •Pregnant or breastfeeding women
- •Patients unable to give consent
Outcomes
Primary Outcomes
The primary endpoint is progression-free survival (PFS)
The primary endpoint is progression-free survival (PFS)
Secondary Outcomes
- 1. Safety profile defined by the number of adverse events classified according to the NCI-CTCAE5.0 classification. Particularly focused on AEs which are known to be linked to bevacizumab: hypertension, proteinuria, etc.
- 2. Overall survival defined as the time elapsed between the date of randomization and death (all causes),
- 3. Rate of best objective tumor response according to RECIST v1.1 criteria (evaluated over the entire duration of treatment).
- 4. Depth of tumor response defined as the percentage of tumor reduction observed at the lowest point.
- 5. Secondary resection of metastases (assessed over the entire treatment period)
- 6. Quality of life: EORTC QLQ-C30 and EQ5D-5L.
- 7. Serum concentrations of bevacizumab on day 14 of the first administration, and at 2 months from randomization (= 3 months from day 1 of the first cycle).
- 8. Medical-economic analysis: estimation of the Differential Cost-Utility Ratio expressed as cost per QALY gained (year of life provided on quality) and the Differential Cost-Effectiveness Ratio expressed as cost per year of life gained.
Investigators
Pr Thierry LECOMTE
Scientific
Centre Hospitalier Regional Universitaire De Tours
Study Sites (19)
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