Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer (JCOG0702): Results for the group with PTV⩾100cc

Radiother Oncol. 2017 Feb;122(2):281-285. doi: 10.1016/j.radonc.2016.11.022. Epub 2016 Dec 16.


Purpose: A dose escalation study to determine the recommended dose (RD) with stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinomas (NSCLC) was conducted. The results of the group with PTV⩾100cc are reported in this paper.

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 maximum tolerated dose (MTD). Dose limiting toxicity (DLT) was Grade 3 or higher radiation pneumonitis (RP), and Grade 2 or higher RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV.

Results: Thirteen patients were accrued. More patients should have been enrolled but we decided not to prolong the study period. No patients experienced Grade 3 RP. Two patients experienced Grade 2 RP at 50Gy in 4 fractions. The predicted MTD was 50.2Gy. The posterior probability of the Grade 2 RP frequency over 40% was 5.3% for the dose level of 50Gy. The RD was determined to be 50Gy.

Conclusions: The RD was determined to be 50Gy in 4 fractions in this population.

Keywords: Continual reassessment method; Dose escalation study; Non-small cell lung cancer (NSCLC); Stereotactic body radiotherapy (SBRT).

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Aged
  • Aged, 80 and over
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Carcinoma, Non-Small-Cell Lung / radiotherapy*
  • Female
  • Humans
  • Lung Neoplasms / pathology
  • Lung Neoplasms / radiotherapy*
  • Male
  • Maximum Tolerated Dose
  • Radiation Pneumonitis / etiology
  • Radiosurgery*
  • Radiotherapy Dosage
  • Tumor Burden