drugset / Trial / NCT06162650

Total Neoadjuvant Therapy in Rectal Cancer

NCT06162650 ↗

Phase 2 Recruiting 42 enrolled National Cheng-Kung University Hospital
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

EvaluationDrugModalityDoseRoute
Background Leucovorin Small molecule 400 mg/m2 —
Background Oxaliplatin Small molecule 85 mg/m2 —
Background fluorouracil Small molecule 2400 mg/m2 —

Indications