Detailed Information

Cited 5 time in webofscience Cited 5 time in scopus
Metadata Downloads

A Randomized Phase 2 Trial of Consolidation Chemotherapy After Preoperative Chemoradiation Therapy Versus Chemoradiation Therapy Alone for Locally Advanced Rectal Cancer: KCSG C0 14-03

Authors
Kim, Sun YoungJoo, JungnamKim, Tae WonHong, Yong SangKim, Jeong EunHwang, In GyuKim, Beom GyuLee, Keun-WookKim, Ji-WonOh, Ho-SukAhn, Joong BaeZang, Dae YoungKim, Dae YongOh, Jae HwanBaek, Ji Yeon
Issue Date
Jul-2018
Publisher
ELSEVIER SCIENCE INC
Citation
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, v.101, no.4, pp 889 - 899
Pages
11
Journal Title
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
Volume
101
Number
4
Start Page
889
End Page
899
URI
https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/933
DOI
10.1016/j.ijrobp.2018.04.013
ISSN
0360-3016
1879-355X
Abstract
Purpose: Preoperative chemoradiation therapy (CRT) followed by total mesorectal excision (TME) in locally advanced rectal cancer is the standard of care. To date, the role of consolidation chemotherapy after CRT has rarely been addressed through randomized trials. This study aimed to evaluate the efficacy of CRT followed by consolidation chemotherapy compared with CRT alone. Methods and Materials: This study enrolled patients with adenocarcinoma of the rectum and cT3 or cT4 disease with any N category and no metastasis. In arm A (control arm), we planned CRT (50.4 Gy in 28 fractions) with capecitabine followed by TME. In arm B, 2 cycles of capecitabine and oxaliplatin were administered 1 week after the completion of CRT before TME (capecitabine, 1700 mg/m(2) per day from day 1 to 14, and oxaliplatin, 100 mg/m(2) on day 1, every 3 weeks). The downstaging rate (the proportion of ypT0 to ypT2 and ypNOMO) was the primary endpoint, which was to be tested with a 1-sided type I error of 15% and with 85% power. Results: From September 2014 to February 2016, 110 patients (56 in arm A and 54 in arm B) were randomized and 108 (55 in arm A and 53 in arm B) started CRT. TME was conducted per protocol in 96 patients (52 in arm A and 44 in arm B). In arms A and B, downstaging was achieved in 21.2% and 36.4% (P = .077), respectively, and the pathologic complete response rate was 5.8% and 13.6% (P = .167), respectively. Grade >= 3 adverse events occurred in 3.6% of patients in arm A and 9.4% of patients in arm B during the preoperative treatment phase and in 1.9% and 9.0%, respectively, during the postoperative recovery phase. Conclusions: Consolidation chemotherapy with 2 cycles of capecitabine and oxaliplatin demonstrated a marginal improvement in the downstaging rate. However, a phase 3 trial of this strategy is discouraged because of the high dropout rate and safety issues. (C) 2018 Published by Elsevier Inc.
Files in This Item
There are no files associated with this item.
Appears in
Collections
ETC > 1. Journal Articles

qrcode

Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.

Related Researcher

Researcher Hwang, In Gyu photo

Hwang, In Gyu
의과대학 (의학부(임상-서울))
Read more

Altmetrics

Total Views & Downloads

BROWSE