TY - JOUR
T1 - 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)
AU - Onimaru, Rikiya
AU - Shirato, Hiroki
AU - Shibata, Taro
AU - Hiraoka, Masahiro
AU - Ishikura, Satoshi
AU - Karasawa, Katsuyuki
AU - Matsuo, Yukinori
AU - Kokubo, Masaki
AU - Shioyama, Yoshiyuki
AU - Matsushita, Haruo
AU - Ito, Yoshinori
AU - Onishi, Hiroshi
N1 - 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. 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. Kokubo reports receipt of grants and personal fees from Mitsubishi Heavy Industries, Ltd., and grants from Elekta Japan, outside the submitted work.
Publisher Copyright:
© 2015 Elsevier Ireland Ltd.
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84953839958&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84953839958&partnerID=8YFLogxK
U2 - 10.1016/j.radonc.2015.07.008
DO - 10.1016/j.radonc.2015.07.008
M3 - Article
C2 - 26233591
AN - SCOPUS:84953839958
SN - 0167-8140
VL - 116
SP - 276
EP - 280
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
IS - 2
ER -
