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Single vs Multi-fraction SRS Patients on Immunotherapy (MIGRAINE)

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ClinicalTrials.gov Identifier: NCT04427228
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
This study is meant to compare different surgical approaches to brain cancer.

Condition or disease Intervention/treatment Phase
Brain Cancer Brain Metastases Radiation: Radiosurgery Single Treatment Radiation: Radiosurgery Three Treatments Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: MIGRAINE: Randomized trIal of Single Versus Multifraction Radiosurgery on Immunotherapy
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : July 10, 2023
Estimated Study Completion Date : July 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A Radiation: Radiosurgery Three Treatments
Multi-fraction SRS. Three small doses done on each brain tumor. 27 Gy in 3 fractions in the multi-fraction group
Other Name: SRS
Active Comparator: ARM B Radiation: Radiosurgery Single Treatment
Frameless single-fraction SRS. One large treatment done on each brain tumor. 20 Gy for GTVs (or resection cavity CTVs) < 2 cm, and 18 Gy for GTVs (or resection cavity CTVs) between 2-3 cm in the single-fraction.
Other Name: SRS


Outcome Measures
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Primary Outcome Measures :
  1. Multi-Fraction SRS superiority compared to single fraction SRS [ Time Frame: 4 years ]
    To determine if Multi-Fraction SRS will decrease the rate of radionecrosis when compared to single-fraction SRS for patients with small metastases and are on immunotherapy.


Secondary Outcome Measures :
  1. Target metastasis progression [ Time Frame: 4 years ]
    Target metastasis progression will be assessed using adapted Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) consensus imaging criteria. In brief, progressive disease is defined as a ≥20% relative increase in the longest diameter (LD) of the target metastasis compared to its smallest LD recorded on study, with a minimum absolute increase of 5 mm

  2. Overall Survival Rate [ Time Frame: 4 years ]
    Time from randomization to death

  3. Acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities [ Time Frame: 4 years ]
    Any acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities, within 90 days of SRS completion (toxicity must be specified).

  4. Late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities [ Time Frame: 4 years ]
    Any late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities, greater than 90 days from SRS completion (toxicity must be specified).

  5. rate of individual metastases radionecrosis [ Time Frame: 4 years ]
    To compare the rates over time of individual metastases radionecrosis using a parametric survival analysis

  6. rate of individual metastases rates of edema [ Time Frame: 4 years ]
    To compare rates over time of individual metastases rates of edema using a parametric survival analysis.

  7. Rates of Symptomatic Edema [ Time Frame: 1 year ]
    To compare rates of symptomatic edema at 3 months, 6 months, and 1 year.1

  8. Time to any distant intracranial failure [ Time Frame: 4 years ]
    Time to any distant intracranial failure (ie, appearance of brain metastasis at untreated site).

  9. Time to initiation of any combination [ Time Frame: 4 years ]
    Time to initiation of any combination of death, salvage SRS, WBRT, or neurosurgical resection for intracranial failure.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427228


Contacts
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Contact: Benjamin Onderdonk, MD 773-702-6870 bonderdonk@radonc.uchicago.edu

Locations
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United States, Illinois
University Of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Benjamin Onderdonk, MD    773-702-6870    bonderdonk@radonc.uchicago.edu   
Principal Investigator: Steven Chmura, MD         
Sub-Investigator: Benjamin Onderdonk, MD         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Steven Chmura, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04427228    
Other Study ID Numbers: IRB19-2022
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases