A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph
nodes and followed by a coned-down boost of 5.4 Gy to the tumor are delivered concurrently
Cetuximab 400 mg/m2 is given intravenously on D-6 (1 week before radiation), followed by 250
mg/m2 once a week (D 1, 8, 15, 22 & 29).
Administration of irinotecan and capecitabine starts on day 1 of radiotherapy. Capecitabine
is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday)
during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22
Four to eight weeks after completion of chemoradiotherapy, curative surgery is performed.
Safety evaluation of the study will be performed after the first 6 patients treated. If more
than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or
irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic stage Tumor regression grade
Kyung Hae Jung, M.D.Ph.D
Korea: Food and Drug Administration