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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Enrolling

Phase 2

Conditions

Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Treatments

Drug: modified FOLFORINOX

Drug: Modified FOLFOX

Study type

Interventional

Funder types

Other

Identifiers

NCT06278545

MANFREDI PHRCK 2022

Details and patient eligibility

About

Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.

The primary objective is to assess the percentage of patients alive without prograssion at 8 months.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 must agree to use contraception during the trial treatment and for at least 9 months after stopping 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. according to MDRD
Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment.
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
Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (refer to paragraph 8.3 "Contraindicated treatments" of the protocol)
Patients currently undergoing treatment using St John's Wort
Treatment with brivudine within 4 weeks prior to the administration of protocol