Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Inclusion Criteria:

• Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum)
• Metastatic or locally advanced unresectable tumour with curative intent
• Patient who never received first-line chemotherapy
• Measurable lesion according to RECIST 1.1 criteria
• ECOG status < or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years
• Life expectancy estimated at over 3 months
• Patient over 18 years of age
• Patient able to understand and sign the information and informed consent note
• Women of childbearing age and men who have sex with women of childbearing age mustagree to use contraception during the trial treatment and for at least 9 months afterstopping the experimental treatments.

Exclusion Criteria:

• MSI/dMMR tumor
• Adenocarcinoma of the ampulla of Vater
• Neutrophils < 1500/mm3, platelets < 100 000/mm3
• Hemoglobin < 9 g/dL, total bilirubin > 1.5x normal, alkaline phosphatase > 2.5x normal (or >5x normal if liver metastases), creatinine clearance > or = 40 ml/min. accordingto MDRD
• Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, itmust be corrected before enrolment.
• Adjuvant chemotherapy completed less than 6 months ago
• History of myocardial infarction within the last 6 months, severe coronary arterydisease or severe heart failure
• Severe renal failure
• Peripheral sensory neuropathy with functional discomfort
• Active and/or potentially severe infection or other uncontrolled conditions
• Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administrationof the protocol treatment (refer to paragraph 8.3 "Contraindicated treatments" of theprotocol)
• Patients currently undergoing treatment using St John's Wort
• Treatment with brivudine within 4 weeks prior to the administration of protocol