A phase I/II trial of stereotactic body radiation therapy (SBRT) for lung metastases: Initial report of dose escalation and early toxicity
- Department of Radiation Oncology, University of Colorado Health Sciences Center, Aurora, CO (United States)
- Division of Medical Oncology, University of Colorado Health Sciences Center, Aurora, CO (United States)
- Section of Thoracic Surgery, University of Colorado Health Sciences Center, Aurora, CO (United States)
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 (V{sub 15}) 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.
- OSTI ID:
- 20850204
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 66, Issue 4; Other Information: DOI: 10.1016/j.ijrobp.2006.08.018; PII: S0360-3016(06)02730-1; Copyright (c) 2006 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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