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A phase II clinical trial of frameless fractionated stereotactic radiotherapy for brain metastases.

ABSTRACT: Stereotactic radiotherapy (SRT) yields high rates of local control for brain metastases, but rural/suburban patients face geographic and socioeconomic barriers to access SRT. We conducted a Phase 2 clinical trial of frameless fractionated stereotactic radiotherapy (FFSRT) for brain metastases in an integrated academic satellite network for patients ≥18-years-old with 1-4 brain metastases. Dose was based on gross tumor volume (GTV) size: < 3.0 cm, 27 Gy in 3 fractions, and 3.0-3.9 cm, 30 Gy in 5 fractions. Median follow-up was 10 months for 73 evaluable patients with median age of 68 years. Median intracranial progression free survival (PFS) was 7.1 months (95% confidence interval (CI): 5.3-not reached (NR)), median survival 7.2 months (95% CI: 5.4-NR), and there were no severe adverse events. Outcomes of this trial compare favorably with contemporary trials and this treatment strategy provides opportunities to expand SRT access to underserved populations.

SUBMITTER: Garg AK

PROVIDER: S-EPMC10715838 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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

Garg Amit K AK Hernandez Mike M Schlembach Pamela J PJ Bowers John R JR McAleer Mary F MF Brown Paul D PD Gopal Ramesh R Wiederhold Lee L Swanson Todd T Shah Shalin J SJ Li Jing J Ferguson Sherise D SD Philip Nancy V NV DeGracia Lilybeth L Bloom Elizabeth S ES Chun Stephen G SG

JNCI cancer spectrum 20231001 6

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 ...[more]

PMID: 37944053

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Project description:BackgroundStereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases.MethodsPatients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15-24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life.DiscussionCurrently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure.Trial registrationClincalTrials.gov, trial registration number: NCT05346367 , trial registration date: 26 April 2022.

Project description:One third of all cancer patients will develop bone metastases and the vertebral column is involved in approximately 70% of these patients. Conventional radiotherapy with of 1-10 fractions and total doses of 8-30?Gy is the current standard for painful vertebral metastases; however, the median pain response is short with 3-6 months and local tumor control is limited with these rather low irradiation doses. Recent advances in radiotherapy technology - intensity modulated radiotherapy for generation of highly conformal dose distributions and image-guidance for precise treatment delivery - have made dose-escalated radiosurgery of spinal metastases possible and early results of pain and local tumor control are promising. The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study. 1) A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety. 2) Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment. 3) Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ??2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this two-centre phase II trial.Results of this study will refine the methods of patient selection, target volume definition, treatment planning and delivery as well as quality assurance for radiosurgery. It is the intention of this study to form the basis for a future randomized controlled trial comparing conventional radiotherapy with fractionated radiosurgery for palliation of painful vertebral metastases.ClinicalTrials.gov Identifier: NCT01594892.

Dataset Information

A phase II clinical trial of frameless fractionated stereotactic radiotherapy for brain metastases.

Publications

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

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