NCT06278545

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2024-02-16
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: France