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Clinical Trial
. 2023 Oct 31;7(6):pkad093.
doi: 10.1093/jncics/pkad093.

A phase II clinical trial of frameless, fractionated stereotactic radiation therapy for brain metastases

Amit K Garg  1 , Mike Hernandez  2 , Pamela J Schlembach  3 , John R Bowers  1 , Mary F McAleer  3 , Paul D Brown  4 , Ramesh Gopal  5 , Lee Wiederhold  3 , Todd Swanson  3 , Shalin J Shah  3 , Jing Li  3 , Sherise D Ferguson  6 , Nancy V Philip  3 , Lilybeth DeGracia  3 , Elizabeth S Bloom  3 , Stephen G Chun  3
Affiliations
Clinical Trial

A phase II clinical trial of frameless, fractionated stereotactic radiation therapy for brain metastases

Amit K Garg et al. JNCI Cancer Spectr. .

Abstract

Stereotactic radiation therapy yields high rates of local control for brain metastases, but patients in rural or suburban areas face geographic and socioeconomic barriers to its access. We conducted a phase II clinical trial of frameless, fractionated stereotactic radiation therapy for brain metastases in an integrated academic satellite network for patients 18 years of age or older with 4 or fewer brain metastases. Dose was based on gross tumor volume: less than 3.0 cm, 27 Gy in 3 fractions and 3.0 to 3.9 cm, 30 Gy in 5 fractions. Median follow-up was 10 months for 73 evaluable patients, with a median age of 68 years. Median intracranial progression-free survival was 7.1 months (95% confidence interval = 5.3 to not reached), and median survival was 7.2 months (95% confidence interval = 5.4 to not reached); there were no serious adverse events. Outcomes of this trial compare favorably with contemporary trials, and this treatment strategy provides opportunities to expand stereotactic radiation therapy access to underserved populations.

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Conflict of interest statement

Dr Chun reports financial relationships with AstraZeneca (consultant), Curio Science (consultant/honorarium), Norton Healthcare (consultant), ViewRay (travel fees), the Japanese Society for Radiation Oncology (honorarium), Henry Ford Health Systems (honorarium), Hong Kong Precision Oncology Society (honorarium), and the Binaytara Foundation (honorarium), all outside the submitted work. Dr Brown discloses a financial relationship with UpToDate (honorarium) outside the submitted work.

Figures

Figure 1.
Figure 1.
Frameless, fractionated stereotactic radiation therapy phase II clinical trial profile.
Figure 2.
Figure 2.
A) Cumulative incidence of local lesion failure, with death as a competing risk. B) Kaplan-Meier plot of intracranial progression-free survival (PFS). C) Kaplan-Meier plot of overall survival.
See this image and copyright information in PMC

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