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Title: Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
Authors: Vutisiri Veerasarn
Pramook Phromratanapongse
Vicharn Lorvidhaya
Prasert Lertsanguansinchai
Chawalit Lertbutsayanukul
Apichart Panichevaluk
Wiroon Boonnuch
Vitoon Chinswangwatanakul
Darin Lohsiriwat
Arun Rojanasakul
Parinya Thavichaigarn
Paiboon Jivapaisarnpong
Mahidol University
Phramongkutklao Hospital
Chiang Mai University
Chulalongkorn University
Rajavithi Hospital
Keywords: Medicine
Issue Date: 1-Nov-2006
Citation: Journal of the Medical Association of Thailand. Vol.89, No.11 (2006), 1874-1884
Abstract: 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.
ISSN: 01252208
Appears in Collections:Scopus 2006-2010

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