drugset / Trial / NCT03085992
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free survival at two years. Translational analyses will be performed to show the presence of VEGF polymorphism, CD133 surface markers on colorectal CSCs.
Timeline
- Start
- 2012-03
- Primary completion
- 2017-07
- Completion
- 2018-03-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 165 mg/m2 | Intravenous |
| Subject | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 225 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 3200 mg/m2 | — |