A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
This study is an open-label, single center, nonrandomized phase II study. 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 were delivered concurrently with chemotherapy.
Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose
of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy.
Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 & 29).
Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed.
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after
surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be
administered for 18 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic stage Tumor regression grade
Kyung Hae Jung, M.D.
Korea: Food and Drug Administration