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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma
• Intervention / Treatment: Drug: modified FOLFORINOX; Drug: Modified FOLFOX

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Thomas APARICIO; Phone Number: +33 01 42 49 95 97; Email: Thomas.aparicio@aphp.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourgogne
    • Contact: Sylvain MANFREDI; Phone Number: +33 03 80 29 37 50; Email: sylvain.manfredi@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified FOLFIRINOX regimen D1=D15 (1 course every 14 days)	Drug: modified FOLFORINOX; One treatment every 14 days : Irinotecan 180mg/m² as a 2-hour IV infusion; Oxaliplatin 85 mg/m² as a 2-hour IV infusion; Folinic acid 400 mg/m² as 2-hour IV infusion, in Y with oxaliplatin; 5-FU 2400 mg/m² as a continuous IV infusion over 46 hours
Active Comparator: Modified FOLFOX regimen D1=D15 (1 course every 14 days)	Drug: Modified FOLFOX; One treatment every 14 days: Oxaliplatin 85 mg/m by IV infusion over 2 hours; Folinic acid: 400 mg/m² or 200 mg/m² if laevorotatory form by IV infusion over 2 hours, in Y with oxaliplatin; 5FU bolus: 400 mg/m² per 10-minute IV infusion; 5 FU continuous 2400 mg/m² by IV infusion over 46 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the percentage of patients alive without progression	At 8 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: MANFREDI PHRCK 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No