drugset / Trial / NCT02942563
Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The concurrent neoadjuvant chemoradiation therapy is standard care for local advanced rectal cancer (LARC), however, this regimen may induce sorts of adverse events, and part of them even more severer. A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone, but the results did not increase the ratio of pathological complete response (pCR), which was associated with overall survival (OS). Here, the investigators adopt the three active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) as the neoadjuvant chemotherapy regimen to replace the concurrent chemoradiation and to improve the ratio of pCR further.
Timeline
- Start
- 2016-11-01
- Primary completion
- 2019-09-30
- Completion
- 2022-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | Oral |
| Subject | Irinotecan | Small molecule | 165 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 135 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2800 mg/m2 | — |