A Single-Arm Prospective Trial Evaluating The Local And Systemic Benefits Of Oxaliplatin And 5FU With Concurrent Radiation In Patients With Metastatic Rectal Cancer
- Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1
concurrent with oxaliplatin over 2 hrs, then 5-FU 400mg/m2 bolus Day 1, then 5-FU
continuous infusion 2.4 g/m2 over 46 hours from Day 1.
- Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2
oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of
- Week 6: as per Week 1,
- Weeks 8-10: as per Weeks 3-5
- Weeks 11: as per Week 1.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
as per protocol
Peter MacCallum Cancer Centre, Australia
Australia: Therapeutic Goods Administration