@article { author = {Kimura, Kana and Itoh, Yoshiyuki and Okada, Tohru and Kubota, Seiji and Kawamura, Mariko and Nakahara, Rie and Oie, Yumi and Kozai, Yuka and Takase, Yuuki and Tsuzuki, Hidenori and Nishio, Naoki and Hiramatsu, Mariko and Fujimoto, Yasushi and Mizutani, Takefumi and Hirakawa, Akihiro and Naganawa, Sinji}, title = {Study Protocol: Prospective Study of Concurrent Chemoradiotherapy with S-1 and Hypofractionated Radiotherapy for Outpatients with Early Glottic Squamous Cell Carcinomas}, journal = {Asian Pacific Journal of Cancer Prevention}, volume = {19}, number = {5}, pages = {1195-1199}, year = {2018}, publisher = {West Asia Organization for Cancer Prevention (WAOCP), APOCP's West Asia Chapter.}, issn = {1513-7368}, eissn = {2476-762X}, doi = {10.22034/APJCP.2018.19.5.1195}, abstract = {Background: The recommended treatment strategies for early glottic carcinoma with intent of larynx preservation areprimarily radiotherapy. However, the outcomes of radiotherapy for bulky T1 or T2 glottic carcinoma are unsatisfactory.We designed a protocol consisting of concurrent chemoradiotherapy using S-1 as the radiosensitizer. We have performedthis protocol in patients with favorable T2 lesions and demonstrated its efficacy and safety. In contrast, we havetreated non-bulky T1 glottic carcinomas with 2.25 Gy per fraction, for a total of 25-28 fractions, starting in 2011 toimprove efficacy and shorten the treatment period. Since this treatment strategy was implemented for T1 disease, nolocal failure has occurred to date, and it appears to be almost as safe as radiotherapy using 2.0 Gy per fraction. Withthe aim of improving the local control rate and shortening the treatment period primarily for favorable T2 disease, wechanged the dose of radiation in our protocol from 2.0 Gy to 2.25 Gy per fraction, for a total of 25 fractions (from 30fractions). The present study aims to evaluate the efficacy and safety of this new protocol. Methods: This study willbe conducted as a clinical, prospective, single-armed, non-randomized trial. Patients are to receive S-1 (55.3 mg /m2/day, once daily) and radiotherapy (2.25 Gy per fraction, for a total of 25 fractions). S-1 and radiotherapy are startedon the same day that radiotherapy is performed, 3-6 hours after oral administration of S-1. The primary study aim isthe 3-year local control rate. The secondary study aims are overall survival, voice-preservation survival, disease-freesurvival, complete response rate, completion rate, and toxicity. Result and conclusion: This is the first single-center,non-randomized, prospective study of concurrent chemoradiotherapy with S-1 and hypofractionated radiotherapy tobe conducted. The trial will evaluate the efficacy and safety of our protocol.}, keywords = {S-1,early glottic cancer,concurrent chemoradiotherapy,prospective study,hypofractionated radiotherapy}, url = {https://journal.waocp.org/article_62634.html}, eprint = {https://journal.waocp.org/article_62634_ef031da8956553556e843cf7360eb1d7.pdf} }