OPTIMOX-aflibercept as First-line Therapy in Patients With Unresectable Metastatic Colorectal Cancer

Inclusion Criteria

• •1. Signed and dated informed consent, and willing and able to comply with protocol requirements,
• •2. Histologically proven adenocarcinoma of the colon and/or rectum,
• •3. Metastatic disease confirmed,
• •4. No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy to relapse must be \>6 months for fluoropyrimidine alone or \>12 months for oxaliplatin-based, bevacizumab-based, cetuximab-based therapy,
• •5. Duly documented inoperable metastatic disease, ie not suitable for complete carcinological surgical resection,
• •6. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1,
• •7. Age ≥18 years,
• •8. ECOG Performance status (PS) 0-2,
• •9. Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
• •10. Adequate renal function: serum creatinine level \<150µM,
• •11. Adequate liver function: serum bilirubin ≤3 x upper normal limit (ULN), alkaline phosphatase \<5xULN,
• •12. Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour,
• •13. Baseline evaluations: clinical and blood evaluations performed no more than 2 weeks (14 days) prior to confirmation of eligibility, tumor assessment (chest X ray, CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to confirmation of eligibility,
• •14. For female patients of childbearing potential, negative serum or urine pregnancy test within 1 week (7 days) prior of starting study treatment,
• •15. Female patients of childbearing potential must commit to using reliable and effective methods of contraception during the trial and until at least six months after the end of study treatment. Females are neither pregnant nor in breastfeeding. Male patients with a partner of childbearing potential must agree to use effective contraception in addition to the contraceptive method used by their partner during the trial and until at least six months after the end of study treatment.
• •16. Registration in a national health care system (CMU included for France).