Brain CancerPhase 2MIGRAINENCT04427228
Single vs Multi-fraction SRS Patients on Immunotherapy
A Phase 2 study testing Radiosurgery Single Treatment and Radiosurgery Three Treatments in people with Brain Cancer and Brain Metastases, run by University of Chicago at 1 site in United States.
Trial summary
This study is meant to compare different surgical approaches to brain cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Brain Metastases
- What is being tested?
- Radiosurgery Single Treatment and Radiosurgery Three Treatments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 12 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
- Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-10 newly diagnosed intraparenchymal brain metastases.
- 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.
- Negative urine or serum pregnancy test done ≤ 21 days prior to CT simulation, for women of child bearing potential only.
- Ability to understand and willingness to sign a written informed consent document.
- 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.
- 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).
Who cannot join
- 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).
- Diagnosis of leptomeningeal disease. iv. Prior SRS to an immediately adjacent lesion(s) of interest or to the current lesion(s) of interest.
- Prior history of pseudoprogression or radionecrosis from cranial radiotherapy.
- A neurosurgical resection cavity deemed too large by the radiation oncologist to be treated with a single fraction of stereotactic radiosurgery.
- Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR <30, gadolinium allergy).
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIGRAINE: Randomized trIal of Single Versus Multifraction Radiosurgery on Immunotherapy
This study is meant to compare different surgical approaches to brain cancer.
- Conditions
- Brain Cancer, Brain Metastases
- Being tested
- Radiosurgery Single Treatment, Radiosurgery Three Treatments
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgery Single TreatmentRadiation
Also called SRS
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.
Radiosurgery Three TreatmentsRadiation
Also called SRS
Multi-fraction SRS. Three small doses done on each brain tumor. 27 Gy in 3 fractions in the multi-fraction group
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Radiation: Radiosurgery Three Treatments |
| ARM B | Active comparator | Not described Receives: Radiation: Radiosurgery Single Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-Fraction SRS superiority compared to single fraction SRS
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.
Measured: 4 years
Secondary outcomes (9)
Target metastasis progression
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
Measured: 4 years
Overall Survival Rate
Time from randomization to death
Measured: 4 years
Acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities
Any acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities, within 90 days of SRS completion (toxicity must be specified).
Measured: 4 years
Late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities
Any late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities, greater than 90 days from SRS completion (toxicity must be specified).
Measured: 4 years
rate of individual metastases radionecrosis
To compare the rates over time of individual metastases radionecrosis using a parametric survival analysis
Measured: 4 years
rate of individual metastases rates of edema
To compare rates over time of individual metastases rates of edema using a parametric survival analysis.
Measured: 4 years
Rates of Symptomatic Edema
To compare rates of symptomatic edema at 3 months, 6 months, and 1 year.1
Measured: 1 year
Time to any distant intracranial failure
Time to any distant intracranial failure (ie, appearance of brain metastasis at untreated site).
Measured: 4 years
Time to initiation of any combination
Time to initiation of any combination of death, salvage SRS, WBRT, or neurosurgical resection for intracranial failure.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start29 Jun 2020
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Why it stopped: unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Chmura, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427228
- Sponsor's protocol ID
- IRB19-2022
- Acronym
- MIGRAINE
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2020
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIGRAINE: Randomized trIal of Single Versus Multifraction Radiosurgery on Immunotherapy
- ClinicalTrials.gov ID
- NCT04427228
- Acronym / sponsor ID
- MIGRAINE / IRB19-2022
- Conditions
- Brain Cancer, Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is meant to compare different surgical approaches to brain cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Radiation: Radiosurgery Three Treatments |
| ARM B | Active comparator | Radiation: Radiosurgery Single Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
- Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-10 newly diagnosed intraparenchymal brain metastases.
- 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.
- Negative urine or serum pregnancy test done ≤ 21 days prior to CT simulation, for women of child bearing potential only.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (6 listed)
- 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).
- Diagnosis of leptomeningeal disease. iv. Prior SRS to an immediately adjacent lesion(s) of interest or to the current lesion(s) of interest.
- Prior history of pseudoprogression or radionecrosis from cranial radiotherapy.
- A neurosurgical resection cavity deemed too large by the radiation oncologist to be treated with a single fraction of stereotactic radiosurgery.
- Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR <30, gadolinium allergy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiosurgery Single TreatmentAlso: SRSFrameless 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. | Radiation | ARM B |
| Radiosurgery Three TreatmentsAlso: SRSMulti-fraction SRS. Three small doses done on each brain tumor. 27 Gy in 3 fractions in the multi-fraction group | Radiation | Arm A |
Primary outcome
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.
9 secondary outcomes
Target metastasis progression
Time frame: 4 years
Overall Survival Rate
Time frame: 4 years
Acute CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities
Time frame: 4 years
Late CTCAE v5.0 CNS Grade 2+ and Grade 3+ toxicities
Time frame: 4 years
rate of individual metastases radionecrosis
Time frame: 4 years
rate of individual metastases rates of edema
Time frame: 4 years
Rates of Symptomatic Edema
Time frame: 1 year
Time to any distant intracranial failure
Time frame: 4 years
Time to initiation of any combination
Time frame: 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Chmura, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiosurgery Single Treatment and Radiosurgery Three Treatments in people with Brain Cancer and Brain Metastases, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-Fraction SRS superiority compared to single fraction SRS (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.