Total Neoadjuvant Therapy in Rectal Cancer
A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
National Cheng-Kung University Hospital
42 participants
Nov 16, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Short-course radiotherapy, 5×5 Gy.
Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles
Locations(1)
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NCT06162650