Publication: Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
Issued Date
2006-11-01
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ISSN
01252208
01252208
01252208
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2-s2.0-33845495420
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.89, No.11 (2006), 1874-1884
Suggested Citation
Vutisiri Veerasarn, Pramook Phromratanapongse, Vicharn Lorvidhaya, Prasert Lertsanguansinchai, Chawalit Lertbutsayanukul, Apichart Panichevaluk, Wiroon Boonnuch, Vitoon Chinswangwatanakul, Darin Lohsiriwat, Arun Rojanasakul, Parinya Thavichaigarn, Paiboon Jivapaisarnpong Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial). Journal of the Medical Association of Thailand. Vol.89, No.11 (2006), 1874-1884. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/23521
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Title
Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial)
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.