drugset / Trial / NCT05018182
FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.
Timeline
- Start
- 2021-08-02
- Primary completion
- 2022-04
- Completion
- 2022-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2800 mg/m2 | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |