A phase I/II trial of stereotactic body radiation therapy (SBRT) for lung metastases: Initial report of dose escalation and early toxicity

Tracey E. Schefter, Brian D. Kavanagh, David Raben, Madeleine Kane, Changhu Chen, Kelly Stuhr, Karen Kelly, John D. Mitchell, Paul A. Bunn, Laurie E. Gaspar

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23 Scopus citations


Purpose: To determine the maximum tolerated dose (MTD) of stereotactic body radiation therapy (SBRT) for lung metastases. Methods and Materials: A Phase I clinical trial was conducted. Eligible patients had one to three pulmonary metastases from a solid tumor, cumulative tumor diameter <7 cm, and adequate pulmonary function (forced expiratory volume in 1 s ≥1.0 L). The planning target volume (PTV) was typically constructed from the gross tumor volume (GTV) by adding a 5-mm radial and 10-mm craniocaudal margin. The first cohort received 48 Gy to the PTV in three fractions (F). SBRT dose was escalated in subsequent cohorts up to a preselected maximum of 60 Gy/3 F. The percent of normal lung receiving more than 15 Gy (V15) was restricted to less than 35%. Respiratory control and a dynamic conformal arc SBRT technique were used. Dose-limiting toxicity (DLT) included acute Grade 3 lung or esophageal toxicity or any acute Grade 4 toxicity within 3 months. After the Phase I dose escalation, the trial continued as a Phase II study, and patients in this cohort are included to increase the number of patients evaluable for early toxicity assessment. Results: Twenty-five eligible patients have been enrolled to date. In the Phase I component of the trial, there were 12 patients (7 male, 5 female): median age, 55 years (range, 31-83 years); the most common primary site was colorectal (4 patients). Seven patients had two lung lesions, and 1 patient had three lesions. The median aggregate volume of all GTVs was 18.7 mL (range, 2-40 mL). No patient experienced a DLT, and dose was escalated to 60 Gy/3 F without reaching the MTD; including the additional Phase II cohort patients, 16 patients have been treated to a dose of 60 Gy/3F without experiencing a DLT in the first 3 months. The equivalent uniform dose to the GTV in the highest dose group ranged from 66 to 77 Gy in 3 F. Conclusions: In patients with limited pulmonary metastases, radiobiologically potent doses of SBRT are well tolerated with minimal early toxicity. A Phase II SBRT study of 60 Gy/3 F for lung metastases is ongoing to evaluate local tumor control rates with this regimen and continue surveillance for any late effects.

Original languageEnglish (US)
JournalInternational Journal of Radiation Oncology Biology Physics
Issue number4 SUPPL.
StatePublished - Nov 15 2006
Externally publishedYes


  • lung metastases
  • oligometastases
  • Phase I trial
  • pulmonary irradiation
  • Stereotactic body radiation therapy (SBRT)

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation


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