drugset / Trial / NCT03043729
mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer
Phase 2
Completed
119 enrolled
AIO-Studien-gGmbH
Institut für Klinisch-Onkologische Forschung (IKF) Frankfurt · collabSanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery.
Timeline
- Start
- 2017-03-06
- Primary completion
- 2021-01-11
- Completion
- 2022-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 4 mg/kg | Intravenous |
| Background | Leucovorin | Small molecule | 350 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |