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

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

February 16, 2024

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2029

Conditions
Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Interventions
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"

Trial Locations (1)

21000

RECRUITING

Chu Dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER