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

Int J Clin Oncol. 2017 Oct;22(5):849-856. doi: 10.1007/s10147-017-1125-y. Epub 2017 May 2.

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.

Keywords: Centrally located stage IA; Non-small cell lung cancer (NSCLC); Phase I; SBRT.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Aged
  • Aged, 80 and over
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Carcinoma, Non-Small-Cell Lung / radiotherapy*
  • Dose Fractionation, Radiation
  • Humans
  • Lung Neoplasms / mortality
  • Lung Neoplasms / radiotherapy*
  • Male
  • Middle Aged
  • Radiosurgery / adverse effects*
  • Radiotherapy Dosage