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Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Sponsor: Centre Hospitalier Universitaire Dijon
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.
Official title: Randomized Phase II Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-02-16
Completion Date
2029-02
Last Updated
2024-02-26
Healthy Volunteers
No
Interventions
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
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
Locations (1)
Chu Dijon Bourgogne
Dijon, France