A Randomized Phase II Study of Neoadjuvant Chemoradiotherapy With 5-FU/Leucovorin (FL) vs. TS-1/Irinotecan in Patients With Locally Advanced Rectal Cancer
This is an open-label, randomized phase II study. Patients will be randomly assigned to
either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients
in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day
for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be
treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was
administered orally twice a day after a meal on the day of irradiation (Monday-Friday)
concurrent with radiotherapy. Total 45-50.4 Gy radiations in 25-28 fractions to tumor and
draining lymph nodes will be delivered concurrently. Curative surgery (especially total
mesorectal excision will be considered as 1st choice of surgical procedure) will be
performed for about 4-8 weeks after the completion of chemoradiotherapy. Postoperative
chemotherapy regimen is 5-FU plus leucovorin.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
pathologic complete response rate
To evaluate pathologic complete response rate in patients with resectable rectal cancer teated with neoadjuvant chemoradiotherapy with 5-FU/leucovorin (FL) vs. TS-1/Irinotecan and surgery followed by fluoropyrimidine based adjuvant chemotherapy
every 4 weeks in FL group, every 2 weeks in TS-1/irinotecan group
No
South Korea: Korea Food and Drug Administration (KFDA)
4-2008-0361
NCT01269216
October 2008
February 2017
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