drugset / Trial / NCT04423965
A Trial of Neoadjuvant mFOLFOXIRI Versus CRT in the EMVI Positive LARC
Phase 2
Unknown
220 enrolled
First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Wenzhou Medical University · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).
Timeline
- Start
- 2020-05-12
- Primary completion
- 2022-05-01
- Completion
- 2025-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | 165 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |
Indications
No indication recorded.