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Phase I study of stereotactic body radiation therapy for centrally located stage IA non-small cell lung cancer (JROSG10-1)

Abstract

Background

To investigate the maximum tolerated dose (MTD) and recommended dose (RD) of stereotactic body radiation therapy (SBRT) for centrally located stage IA non-small cell lung cancer (NSCLC).

Methods

Five dose levels, ranging from of 52 to 68 Gy in eight fractions, were determined; the treatment protocol began at 60 Gy (level 3). Each dose level included 10 patients. Levels 1–2 were indicated if more than four patients exhibited dose-limiting toxicity (DLT), which was defined as an occurrence of a grade 3 (or worse) adverse effect within 12 months after SBRT initiation. MTD was defined as the lowest dose level at which more than four patients exhibited DLT.

Results

Ten patients were enrolled in the level 3 study. One patient was considered unsuitable because of severe emphysema. Therefore, nine patients were evaluated and no patient exhibited DLT. The level 3 results indicated that we should proceed to level 4 (64 Gy). However, due to the difficulty involved in meeting the dose constraints, further dose escalation was not feasible and the MTD was found to be 60 Gy.

Conclusions

The RD of SBRT for centrally located stage IA NSCLC was 60 Gy in eight fractions.

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Fig. 1

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Acknowledgements

This study was supported in part by a Grant-in-Aid from the Japanese Radiation Oncology Study Group (JROSG), and the authors would like to thank the JROSG staff office for their helpful support.

Author information

Correspondence to Tomoki Kimura.

Ethics declarations

Conflict of interest

Dr. Harada reports grants from Astrazeneca Co., Chugai Pharmaceutical Co., and Brainlab Co., although they were not received in association with the submitted work.

Funding

This work was supported by the Japanese Radiation Oncology Study Group (JROSG).

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Kimura, T., Nagata, Y., Harada, H. et al. Phase I study of stereotactic body radiation therapy for centrally located stage IA non-small cell lung cancer (JROSG10-1). Int J Clin Oncol 22, 849–856 (2017). https://doi.org/10.1007/s10147-017-1125-y

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Keywords

  • SBRT
  • Phase I
  • Non-small cell lung cancer (NSCLC)
  • Centrally located stage IA