PRODIGE 86-FOLFIRINOX SBA- Phase II randomized trial evaluating modified FOLFIRINOX and FOLFOX in the treatment of locally advanced or metastatic small bowel adenocarcinoma

Phase 1

Recruiting

Conditions: Small bowel adenocarcinoma
Therapeutic area: Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2023-505486-92-00

Lead Sponsor: Centre Hospitalier Universitaire De Dijon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 130

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

Exclusion Criteria

MSI/dMMR tumor, Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment, Uncontrolled inflammatory bowel disease and/or unresolved bowel obstruction, Administration of live vaccines within 28 days prior to randomization, 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. according to MDRD, Adjuvant chemotherapy completed less than 6 months ago, History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure, Severe renal failure, Peripheral sensory neuropathy with functional discomfort, Active and/or potentially severe infection or other uncontrolled conditions

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of the percentage of patients alive without progression at 8 months;Secondary Objective: Overall Survival, Progression-free survival, Time to treatment failure, Better response during first line tratment, Treatment tolerance, Quality of life during treatment, Progression-free survival in 2nd line of total population and by 2nd line treatment;Primary end point(s): Progression at 8 months

Secondary Outcome Measures