Journal Article 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)

Onimaru, Rikiya  ,  Shirato, Hiroki  ,  Shibata, Taro  ,  Hiraoka, Masahiro  ,  Ishikura, Satoshi  ,  Karasawa, Katsuyuki  ,  Matsuo, Yukinori  ,  Kokubo, Masaki  ,  Shioyama, Yoshiyuki  ,  Matsushita, Haruo  ,  Ito, Yoshinori  ,  Onishi, Hiroshi

116 ( 2 )  , pp.276 - 280 , 2015-08 , Elsevier
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.

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