drugset / Trial / NCT03530267
Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer
Phase 2
Completed
124 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
STABIL - Statistische und Biometrische Lösungen · collabSanofi · collabTrium Analysis Online GmbH · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a controlled, open-label, randomized phase- II trial (1:1 randomization) investigating 5-FU + aflibercept and 5-FU + oxaliplatin in elderly and frail elderly patients with mCRC scheduled to receive first line treatment.
Timeline
- Start
- 2018-09-28
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 4 mg/kg | — |
| Subject | Oxaliplatin | Small molecule | 68 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 350 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 1920 mg/m2 | Intravenous |