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Total Neoadjuvant Therapy in Rectal Cancer
Sponsor: National Cheng-Kung University Hospital
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.
Official title: A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2023-11-16
Completion Date
2030-11-16
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Short-course radiotherapy
Short-course radiotherapy, 5×5 Gy.
mFOLFOX6
Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles
Locations (1)
National Cheng Kung University Hospital
Tainan, Taiwan