Clinical trial NCT04427228: Single vs Multi-fraction SRS Patients on Immunotherapy
Official title: MIGRAINE: Randomized trIal of Single Versus Multifraction Radiosurgery on Immunotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Brain Cancer
Brain Metastases
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Multi-Fraction SRS superiority compared to single fraction SRS
timeFrame: 4 years
Secondary outcomes:
measure: Target metastasis progression
timeFrame: 4 years
measure: Overall Survival Rate
timeFrame: 4 years
measure: Acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities
timeFrame: 4 years
measure: Late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities
timeFrame: 4 years
measure: rate of individual metastases radionecrosis
timeFrame: 4 years
measure: rate of individual metastases rates of edema
timeFrame: 4 years
measure: Rates of Symptomatic Edema
timeFrame: 1 year
measure: Time to any distant intracranial failure
timeFrame: 4 years
measure: Time to initiation of any combination
timeFrame: 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Steven Chmura, MD
role: PRINCIPAL_INVESTIGATOR
References: