Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)

Objective: Phase I multicenter study defined the maximal tolerated dose (MTD), dose-limiting toxicity (DLT) and safety profile of capecitabine in combination with preoperative radiation for patients with locally advanced rectal cancer (LARC). Material and Method: Patients were treated with oral cape...

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Main Authors: Veerasarn V., Phromratanapongse P., Lorvidhaya V., Lertsanguansinchai P., Lertbutsayanukul C., Panichevaluk A., Boonnuch W., Chinswangwatanakul V., Lohsiriwat D., Rojanasakul A., Thavichaigarn P., Jivapaisarnpong P.
Format: Article
Language:English
Published: 2014
Online Access:http://www.scopus.com/inward/record.url?eid=2-s2.0-33845495420&partnerID=40&md5=31aee1aa06e324d9dc4b8648a1d6bbd4
http://cmuir.cmu.ac.th/handle/6653943832/2017
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spelling th-cmuir.6653943832-20172014-08-30T02:00:23Z Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial) Veerasarn V. Phromratanapongse P. Lorvidhaya V. Lertsanguansinchai P. Lertbutsayanukul C. Panichevaluk A. Boonnuch W. Chinswangwatanakul V. Lohsiriwat D. Rojanasakul A. Thavichaigarn P. Jivapaisarnpong P. Objective: Phase I multicenter study defined the maximal tolerated dose (MTD), dose-limiting toxicity (DLT) and safety profile of capecitabine in combination with preoperative radiation for patients with locally advanced rectal cancer (LARC). Material and Method: Patients were treated with oral capecitabine (700, 800, 900, 1000, 1100 and 1200 mg/ m2 twice daily continuously) plus preoperative whole pelvic irradiation (45-46 Gy in 23-25 fractions over 5-6 weeks). Surgery was performed at the median of 42 days after chemoradiation treatment. Results: Twenty-seven patients were in this trial. Eighteen patients (3 per dose level) had received capecitabine from 700 mg/m2 twice daily to the highest dose level of 1200 mg/m2 twice daily. There were no grade 3/4 DLTs during dose escalation, a further nine patients were included at the highest capecitabine dose. Two of the twelve patients (16%) receiving capecitabine 1200 mg/m2 twice daily developed grade 3 diarrhea and discontinued treatment. There were no other grade 3/4 adverse events. After capecitabine chemoradiation, 24 of 27 patients (89%) received definite surgery. Primary and lymph node down staging occurred in ten patients (42%). Sphincter-sparing surgery was performed in seven patients (26%) and abdominal-perineal resection was performed in 17 patients (63%). Conclusion: Preoperative capecitabine chemoradiation based on continuous daily capecitabine is very well tolerated in patients with LARC. The authors did not reach the MTD in the present study. 2014-08-30T02:00:23Z 2014-08-30T02:00:23Z 2006 Article 01252208 17205868 JMTHB http://www.scopus.com/inward/record.url?eid=2-s2.0-33845495420&partnerID=40&md5=31aee1aa06e324d9dc4b8648a1d6bbd4 http://cmuir.cmu.ac.th/handle/6653943832/2017 English
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
language English
description Objective: Phase I multicenter study defined the maximal tolerated dose (MTD), dose-limiting toxicity (DLT) and safety profile of capecitabine in combination with preoperative radiation for patients with locally advanced rectal cancer (LARC). Material and Method: Patients were treated with oral capecitabine (700, 800, 900, 1000, 1100 and 1200 mg/ m2 twice daily continuously) plus preoperative whole pelvic irradiation (45-46 Gy in 23-25 fractions over 5-6 weeks). Surgery was performed at the median of 42 days after chemoradiation treatment. Results: Twenty-seven patients were in this trial. Eighteen patients (3 per dose level) had received capecitabine from 700 mg/m2 twice daily to the highest dose level of 1200 mg/m2 twice daily. There were no grade 3/4 DLTs during dose escalation, a further nine patients were included at the highest capecitabine dose. Two of the twelve patients (16%) receiving capecitabine 1200 mg/m2 twice daily developed grade 3 diarrhea and discontinued treatment. There were no other grade 3/4 adverse events. After capecitabine chemoradiation, 24 of 27 patients (89%) received definite surgery. Primary and lymph node down staging occurred in ten patients (42%). Sphincter-sparing surgery was performed in seven patients (26%) and abdominal-perineal resection was performed in 17 patients (63%). Conclusion: Preoperative capecitabine chemoradiation based on continuous daily capecitabine is very well tolerated in patients with LARC. The authors did not reach the MTD in the present study.
format Article
author Veerasarn V.
Phromratanapongse P.
Lorvidhaya V.
Lertsanguansinchai P.
Lertbutsayanukul C.
Panichevaluk A.
Boonnuch W.
Chinswangwatanakul V.
Lohsiriwat D.
Rojanasakul A.
Thavichaigarn P.
Jivapaisarnpong P.
spellingShingle Veerasarn V.
Phromratanapongse P.
Lorvidhaya V.
Lertsanguansinchai P.
Lertbutsayanukul C.
Panichevaluk A.
Boonnuch W.
Chinswangwatanakul V.
Lohsiriwat D.
Rojanasakul A.
Thavichaigarn P.
Jivapaisarnpong P.
Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
author_facet Veerasarn V.
Phromratanapongse P.
Lorvidhaya V.
Lertsanguansinchai P.
Lertbutsayanukul C.
Panichevaluk A.
Boonnuch W.
Chinswangwatanakul V.
Lohsiriwat D.
Rojanasakul A.
Thavichaigarn P.
Jivapaisarnpong P.
author_sort Veerasarn V.
title Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
title_short Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
title_full Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
title_fullStr Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
title_full_unstemmed Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
title_sort preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase i trial)
publishDate 2014
url http://www.scopus.com/inward/record.url?eid=2-s2.0-33845495420&partnerID=40&md5=31aee1aa06e324d9dc4b8648a1d6bbd4
http://cmuir.cmu.ac.th/handle/6653943832/2017
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