skip to main content
OSTI.GOV title logo U.S. Department of Energy
Office of Scientific and Technical Information

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

Abstract

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 themore » 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.« less

Authors:
 [1];  [1];  [1];  [2];  [1];  [1];  [2];  [3];  [2];  [1]
  1. Department of Radiation Oncology, University of Colorado Health Sciences Center, Aurora, CO (United States)
  2. Division of Medical Oncology, University of Colorado Health Sciences Center, Aurora, CO (United States)
  3. Section of Thoracic Surgery, University of Colorado Health Sciences Center, Aurora, CO (United States)
Publication Date:
OSTI Identifier:
20850204
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 66; Journal 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); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; CLINICAL TRIALS; IRRADIATION; LUNGS; METASTASES; PATIENTS; RADIATION DOSES; RADIOTHERAPY; TOXICITY

Citation Formats

Schefter, Tracey E, Kavanagh, Brian D, Raben, David, Kane, Madeleine, Changhu, Chen, Stuhr, Kelly, Kelly, Karen, Mitchell, John D, Bunn, Paul A, and Gaspar, Laurie E. A phase I/II trial of stereotactic body radiation therapy (SBRT) for lung metastases: Initial report of dose escalation and early toxicity. United States: N. p., 2006. Web. doi:10.1016/j.ijrobp.2006.08.018.
Schefter, Tracey E, Kavanagh, Brian D, Raben, David, Kane, Madeleine, Changhu, Chen, Stuhr, Kelly, Kelly, Karen, Mitchell, John D, Bunn, Paul A, & Gaspar, Laurie E. A phase I/II trial of stereotactic body radiation therapy (SBRT) for lung metastases: Initial report of dose escalation and early toxicity. United States. https://doi.org/10.1016/j.ijrobp.2006.08.018
Schefter, Tracey E, Kavanagh, Brian D, Raben, David, Kane, Madeleine, Changhu, Chen, Stuhr, Kelly, Kelly, Karen, Mitchell, John D, Bunn, Paul A, and Gaspar, Laurie E. 2006. "A phase I/II trial of stereotactic body radiation therapy (SBRT) for lung metastases: Initial report of dose escalation and early toxicity". United States. https://doi.org/10.1016/j.ijrobp.2006.08.018.
@article{osti_20850204,
title = {A phase I/II trial of stereotactic body radiation therapy (SBRT) for lung metastases: Initial report of dose escalation and early toxicity},
author = {Schefter, Tracey E and Kavanagh, Brian D and Raben, David and Kane, Madeleine and Changhu, Chen and Stuhr, Kelly and Kelly, Karen and Mitchell, John D and Bunn, Paul A and Gaspar, Laurie E},
abstractNote = {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.},
doi = {10.1016/j.ijrobp.2006.08.018},
url = {https://www.osti.gov/biblio/20850204}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 4,
volume = 66,
place = {United States},
year = {Wed Nov 15 00:00:00 EST 2006},
month = {Wed Nov 15 00:00:00 EST 2006}
}