Status:
WITHDRAWN
Single vs Multi-fraction SRS Patients on Immunotherapy
Lead Sponsor:
University of Chicago
Conditions:
Brain Cancer
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is meant to compare different surgical approaches to brain cancer.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04427228
Start Date
June 29 2020
End Date
December 12 2022
Last Update
August 28 2023
Active Locations (1)
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1
University Of Chicago
Chicago, Illinois, United States, 60637