Single vs Multi-fraction SRS Patients on Immunotherapy

  • STATUS
    Recruiting
  • End date
    Jul 10, 2025
  • participants needed
    74
  • sponsor
    University of Chicago
Updated on 24 January 2021
cancer
measurable disease
metastasis
brain metastases
pd-l1
brain tumor

Summary

This study is meant to compare different surgical approaches to brain cancer.

Details
Condition Malignant neoplasm of brain, Brain Tumor (Pediatric), Brain Metastasis, Brain Metastases, Brain Cancer, Brain Tumor, malignant brain tumor, brain tumors
Treatment Radiosurgery Single Treatment, Radiosurgery Three Treatments
Clinical Study IdentifierNCT04427228
SponsorUniversity of Chicago
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

i. Adult patients ( 18 years old) with an ECOG Performance Status 0-2 and a
life expectancy of 3 months or more
ii. Histologically confirmed systemic malignancy with gadolinium contrast-
enhanced MRI scan demonstrating 1-10 newly diagnosed intraparenchymal brain
metastases
iii. Well-circumscribed, measureable intraparenchymal brain metastasis(s) with
maximum tumor diameter 3.0 cm. If multiple metastases are present, the
other(s) must not exceed 3.0 cm in maximum diameter. At least one metastasis
must be 0.5 cm in maximum diameter to be considered measurable disease
iv. Negative urine or serum pregnancy test done 21 days prior to CT
simulation, for women of child bearing potential only
v. Ability to understand and willingness to sign a written informed consent
document
vi. Must have received immunotherapy (PD-1/PD-L1 and/or CTLA-4 inhibitor(s))
within the past 6 months or plan on receiving immunotherapy within the next 1
month
vii. Must have a Gustave Roussy Immune Score (GRIm-Score) of 0 or 1
(neutrophil-to-lymphocyte ratio > 6 = 1 point, LDH > Upper Limit of Normal = 1
point, and Albumin < 3.5 g/dL = 1 point)

Exclusion Criteria

i. Diagnosis of germ cell tumor or hematologic malignancy. ii. Metastases in
the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus
(optic nerves, chiasm and optic tracts)
iii. Diagnosis of leptomeningeal disease. iv. Prior SRS to an immediately
adjacent lesion(s) of interest or to the current lesion(s) of interest
v. Prior history of pseudoprogression or radionecrosis from cranial
radiotherapy
vi. A neurosurgical resection cavity deemed too large by the radiation
oncologist to be treated with a single fraction of stereotactic radiosurgery
vii. Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible
pacemaker, eGFR <30, gadolinium allergy)
viii. A Gustave Roussy Immune Score (GRIm-Score) > 1 (neutrophil-to-lymphocyte
ratio > 6 = 1 point, LDH > Upper Limit of Normal = 1 point, and Albumin < 3.5
g/dL = 1 point)
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