drugset / Trial / NCT06162650
Total Neoadjuvant Therapy in Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.
Timeline
- Start
- 2023-11-16
- Primary completion
- 2026-11-16
- Completion
- 2030-11-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |