Impact of Using the Oncogramme® Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer

This is an interventional other trial for Metastatic Colorectal Cancer Read More

Inclusion Criteria:

• 18 years old and older
• Patient with suspected mCRC (synchronous or metachronous metastases (only if biopsy is required as part of routine care))
• Patient eligible for standard systemic chemotherapy (multidrug therapy such as FOLFOX, FOLFIRI, FOLFIRINOX, combined or not with anti- EGFR or anti-VEGF targeted therapies adapted to BRAF and RAS expression)
• colorectal adenocarcinoma histologically proven
• At least one measurable metastasis according to RECIST v1.1
• Chemotherapy for curative or palliative purposes
• Oncograms® can be performed
• WHO score ≤ 2
• Life expectancy > 3 months
• neutrophils > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dL
• Total bilirubin < 25 μmol/L, aspartate aminotransferase < 5 ULN (upper limits of normal), alanine aminotransferase < 5 ULN, alkaline phosphatase < 5 ULN, prothrombin rate > 60%, proteinuria < 1 g/24h
• No prior chemotherapy except peri-operative or adjuvant chemotherapy stopped more than 6 months ago
• Creatinine clearance > 50 mL/min according to MDRD formula
• Patient affiliated to a social security scheme
• Information to the patient and signature of the informed consent form.

Exclusion Criteria:

• Patients eligible for curative treatment (surgical and/or percutaneous) after discussion in multidisciplinary consultation meeting (isolated class I liver metastases)
• Patients with metachronous metastases not requiring biopsy as part of their standard management.
• Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, New York Heart Association (NYHA) class II, III, or IV congestive heart failure, stroke, or transient ischemic attack within 6 months prior to inclusion
• HTA not controlled by medical treatment (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
• Active peptic ulcer
• Deep wound or bone fracture not resolved within 3 months
• Major abdominal or extra-abdominal surgical procedure (except diagnostic biopsy or implantable site placement)
• Irradiation within 4 weeks prior to the start of treatment
• Transplant patients, HIV-positive, or other immunodeficiency syndromes
• Previous chemotherapy (except peri-operative or adjuvant chemotherapy discontinued more than 6 months ago)
• Any progressive disease not balanced during the last 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency
• Peripheral neuropathy > 1 (CTCAE Common terminology criteria for adverse eventsv5.0)
• Patient with interstitial lung disease or pulmonary fibrosis
• History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion unresolved with symptomatic treatment
• History of malignancy within the last 5 years except for properly treated non-metastatic colon cancer, basal cell skin carcinoma or carcinoma in situ of the uterine cervix
• Patient already included in another therapeutic trial with an investigational treatment or who has been out of a trial for less than 6 months
• Any specific contraindication or known allergy to the drugs used in the study.
• Known dihydropyrimidine dehydrogenase deficiency
• QT/QTc interval > 450 ms for men and > 470 ms for women
• Kalemia (K+) < LIN (lower limit to normal), magnesemia (Mg2+)< LIN, calcemia (Ca2+)< LIN
• Lack of effective contraception (at least 2 different means) in patients (male or/and female) of childbearing age, or for females, 12 months of confirmed amenorrhea, pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test (serum test)
• Persons deprived of liberty or under guardianship
• Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons.