Brain MetastasesNCT04422639
Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases
A study testing SRS/SRT in people with Brain Metastases, run by University of Arkansas at 1 site in United States.
Trial summary
This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- SRS/SRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 27 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
- MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate both surgery and SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.
- ECOG ≤ 2
- 1-2 index lesion(s) appropriate for resection, not previously treated with SRS/SRT.
- Index lesion(s) should be > 2 cm and < 5 cm in largest dimension, and require resection. Alternatively, patients with a diagnosis of melanoma and a lesion < 1.5cm in largest dimension may also be included. o All other brain lesions must be appropriate for SRS/SRT alone and treated according to physician preference. Prior neurosurgery and/or prior SRS/SRT at a non-overlapping location are permitted at the discretion of the treating physician.
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- MRI confirmed 1-10 lesions, 1-2 of which are the index lesions undergoing surgery.
- Each non-index lesion (up to 10) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.
- Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (≤ 10 metastases).
- Surgical resection able to be performed within 15 days of radiotherapy completion.
- Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
- Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
- Platelet count > 80 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm
Who cannot join
- Not a surgical candidate per neurosurgeon's discretion.
- Contraindication to general anesthesia.
- Not a radiosurgical candidate per radiation oncologist's discretion.
- Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or lymphoma or any primary brain tumor
- ECOG > 2
- < 3 months expected survival
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- Radiologic documentation of hydrocephalus in addition to symptoms of hydrocephalus
- Radiographic or cytologic evidence of leptomeningeal disease.
- Imaging Findings:
- Midline shift > 6mm
- >10 lesions, one of which is the index lesion
- Largest lesion > 5cm
- Pregnancy
- Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants are eligible.
- Patients who have local recurrence of previously treated brain metastasis.
- Patients who have received prior WBRT.
- Inherited radiation hypersensitivity syndromes
- o Ataxia Telangiectasia, Nijmegen Breakage Syndrome, Fanconi Anemia, DNA Ligase IV, Mre 11 deficiency, SCID, Bloom's syndrome
- Collagen vascular diseases
- o Active systemic lupus erythematous (SLE), scleroderma, mixed connective tissue disorder, polymyositis or dermatomyositis, CREST Syndrome
- Cytotoxic Chemotherapy within 7 days prior to SRS/SRT.
- o Molecularly targeted therapies, including immune-modulatory drugs, can be given within 7 days of SRS/SRT at the discretion of the treating physician.
- Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection.
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72223
About this study
Official title: A Phase II Pilot Trial of Preoperative SRS/SRT Versus Postoperative SRS/SRT for Brain Metastases
This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases.
The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain metastases.
The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain metastases will result in improved freedom from Central Nervous System (CNS) events when compared to adjuvant SRS/SRT after surgical resection.
- Conditions
- Brain Metastases
- Being tested
- SRS/SRT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRS/SRTRadiation
Comparing pre-operative SRS/SRT to post-operative SRS/SRT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (pre-operative SRS/SRT) | Experimental | Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment. Receives: Radiation: SRS/SRT |
| Arm II (post-operative SRS/SRT) | Active comparator | Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment. Receives: Radiation: SRS/SRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Central Nervous System (CNS) Composite Event (CE)
A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).
Measured: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start24 Aug 2020
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Why it stopped: Following the EAB for NCI Designation this study was identified as having no funding and not meeting enrollment goals. It was requested by the EAB that this study be closed due to inactivity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Analiz Rodriguez, MD, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422639
- Sponsor's protocol ID
- 260505
- Status last verified
- Jul 2023
- First submitted
- 29 May 2020
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Trial of Preoperative SRS/SRT Versus Postoperative SRS/SRT for Brain Metastases
- ClinicalTrials.gov ID
- NCT04422639
- Acronym / sponsor ID
- 260505
- Conditions
- Brain Metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following the EAB for NCI Designation this study was identified as having no funding and not meeting enrollment goals. It was requested by the EAB that this study be closed due to inactivity.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases.
The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain metastases.
The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain metastases will result in improved freedom from Central Nervous System (CNS) events when compared to adjuvant SRS/SRT after surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (pre-operative SRS/SRT) | Experimental | Radiation: SRS/SRTPatients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment. |
| Arm II (post-operative SRS/SRT) | Active comparator | Radiation: SRS/SRTPatients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
- MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
- Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate both surgery and SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.
- ECOG ≤ 2
- 1-2 index lesion(s) appropriate for resection, not previously treated with SRS/SRT.
Key exclusion criteria (24 listed)
- Not a surgical candidate per neurosurgeon's discretion.
- Contraindication to general anesthesia.
- Not a radiosurgical candidate per radiation oncologist's discretion.
- Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or lymphoma or any primary brain tumor
- ECOG > 2
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 |
|---|---|---|
| SRS/SRTComparing pre-operative SRS/SRT to post-operative SRS/SRT | Radiation | Arm I (pre-operative SRS/SRT), Arm II (post-operative SRS/SRT) |
Primary outcome
Number of Participants With Central Nervous System (CNS) Composite Event (CE)
Time frame: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.
A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Analiz Rodriguez, MD, PhD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRS/SRT in people with Brain Metastases, run by University of Arkansas 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 13 inclusion and 24 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: stopped early, as of the sponsor's last update on 28 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Central Nervous System (CNS) Composite Event (CE) (time frame: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.). 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 Jul 2023.