@article{073a7703d72c467988bf00ff23c0efb4,
title = "Phase i study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV < 100 cc using a continual reassessment method (JCOG0702)",
abstract = "Purpose To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc. Materials and methods The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV. Results Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions. Conclusions The RD of SBRT for peripheral T2N0M0 NSCLC with PTV < 100 cc was determined to be 55 Gy in 4 fractions.",
keywords = "Continual reassessment method, Non-small cell lung cancer (NSCLC), Phase I study, SBRT, Stereotactic body radiotherapy",
author = "Rikiya Onimaru and Hiroki Shirato and Taro Shibata and Masahiro Hiraoka and Satoshi Ishikura and Katsuyuki Karasawa and Yukinori Matsuo and Masaki Kokubo and Yoshiyuki Shioyama and Haruo Matsushita and Yoshinori Ito and Hiroshi Onishi",
note = "Funding Information: Dr. Shirato has received grants from the Government, during the conduct of the study; grants from Hitachi, Ltd., grants and personal fees from Mitsubishi Heavy Industries, Ltd., grants and personal fees from Shimadzu Corporation, grants and personal fees from Varian Medical Systems, Inc., and personal fees from Olympus Corporation, outside the submitted work. In addition, Dr. Shirato holds a patent US 6,307,914 with royalties paid. Funding Information: Dr. Hiraoka reports grants from Varian Medical Systems, Inc. and grants from Mitsubishi Heavy Industries, Ltd., outside the submitted work. Funding Information: Dr. Karasawa reports grants from Symbio Pharmaceuticals, outside the submitted work. Funding Information: Dr. Kokubo reports receipt of grants and personal fees from Mitsubishi Heavy Industries, Ltd., and grants from Elekta Japan, outside the submitted work. Funding Information: Operations Office: Dr. Tomonori Mizutani, Dr. Junko Eba, and Dr. Kenichi Nakamura for support in the drafting of the manuscript. Supported in part by the National Cancer Center Research and Development Fund (Grants 23-A-16 , 23-A-21 , and 26-A-4 ), Grants-in-Aid for Cancer Research ( 20S-5 and 20S-6 ), and a Health and Labour Sciences Research Grant for Clinical Research ( 20-020 ) from the Ministry of Health, Labour and Welfare of Japan. ",
year = "2015",
doi = "10.1016/j.radonc.2015.07.008",
language = "English",
volume = "116",
pages = "276--280",
journal = "Radiotherapy and Oncology",
issn = "0167-8140",
publisher = "Elsevier Ireland Ltd",
number = "2",
}