Fractionated Stereotactic Radiosurgery for Large Brain Metastases

  • STATUS
    Recruiting
  • End date
    Dec 22, 2026
  • participants needed
    25
  • sponsor
    Steven Burton
Updated on 22 March 2022

Summary

This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.

Details
Condition Large Brain Mets
Treatment Fractionated Stereotactic Radiosurgery
Clinical Study IdentifierNCT02054689
SponsorSteven Burton
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients ≥ 18 years of age
A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
The target lesion(s) can be accurately measured in at least one dimension according to RECIST
No prior radiotherapy to the brain
Previous or concurrent systemic or targeted chemotherapy is allowed
Patients must have an extra-cranial primary tumor diagnosis
Patients will have no more than 3 distinct lesions within the brain
At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
The additional lesions will each be treated with single fraction stereotactic radiosurgery
Patient may be on steroids or anti-epileptics
Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Patients do not need a histologically proven diagnosis of brain mets

Exclusion Criteria

Symptomatic patients in need of surgery to the "target" lesion
Four or more newly-diagnosed lesions
Prior surgical resection of targeted tumor
Prior WBRT
Primary brain tumor
Pregnant or breast-feeding patients
Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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