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New treatment option for Brain Metastases
Official title EXCLAIM: Exploring Combined Local and Systemic Approaches In Brain Metastasis: a Multi-cohort Randomized Phase II Study Evaluating Initial Response to Systemic Therapy and Subsequent Integration of Stereotactic Radiosurgery in Patients With Low-risk Brain Metastases and Central Nervous System-active
ClinicalTrials.gov ID: NCT06649058
What this study is testing
- What it's testing
- To learn if consolidative stereotactic radiosurgery (cSRS) can help to control central nervous system (CNS) disease in patients who have brain metastases and have a partial response or stable brain metastases after systemic therapy. To learn if using SRS to treat all brain metastases that do not respond to systemic therapy versus treating only metastases that are getting worse can help to control CNS disease in patients whose disease gets worse after systemic therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical...
- Life expectancy \> 6 months as estimated by BM-MDT.
- BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS).
- BM-MDT agreement that the patient's BM does not require immediate local therapy (surgery and/or radiation therapy); i.e. it is judged to be safe to...
You likely can't join if
- History of known leptomeningeal involvement (radiographic or cytological).
- Small cell lung cancer, lymphoma, or leukemia histology.
- Non-small cell lung cancer histology with targetable oncogenic driver mutation with planned initiation of highly CNS active targeted therapy (eg...
- people previously treated with WBRT.
- Any intact BM size \> 3 cm. After surgical excision and appropriate radiation therapy to the cavity, patients may enroll if additional eligible...
- Prior disease progression on one or more of the agents comprising SST.
See the full eligibility criteria
Who can join
- Age ≥ 18 years.
- Evaluation by a brain metastasis multidisciplinary team (BM-MDT) consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a...
- Life expectancy \> 6 months as estimated by BM-MDT.
- BM-MDT agreement that the planned systemic therapy regimen may provide intracranial benefit (SD, PR, or CR in the CNS).
- BM-MDT agreement that the patient's BM does not require immediate local therapy (surgery and/or radiation therapy); i.e. it is judged to be safe to omit local therapy as initial BM management.
- The patient's BM are amenable to SRS as initial local therapy as determined by BM-MDT.
- people must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related...
- Histologically confirmed metastatic cancer with at least one measurable metastasis in the brain (≥ 5 mm).
- At least one measurable intracranial target lesion which was not previously treated with SRS. Regrowth in a cavity of previously excised lesion will not qualify as a measurable lesion. Growth or change in a lesion...
- Prior SRS and prior excision of BM is permitted if other measurable non irradiated lesions as described in #9 remain.
- The resection cavity of excised BM must have received appropriate radiation therapy (pre or post operative SRS, brachytherapy) or have been observed for \>6 months after resection without evidence of local cavity...
- people must be free of neurologic signs and symptoms related to metastatic brain lesions either without systemic corticosteroids or requiring ≤ 2 mg dexamethasone daily for symptom resolution.
- ECOG performance status ≤ 1.
- Documented agreement by the patient's primary medical oncologist with the appropriateness of planned SST regimen.
- This study will allow non-English speaking people to be enrolled. Verbal Translation Preparative Sheet (VTPS) will be used if a translated consent form is not available in the subject's language. The consent form will...
What rules you out
- History of known leptomeningeal involvement (radiographic or cytological).
- Small cell lung cancer, lymphoma, or leukemia histology.
- Non-small cell lung cancer histology with targetable oncogenic driver mutation with planned initiation of highly CNS active targeted therapy (eg osimertinib, brigatinib, alectinib, or lorlatinib).
- people previously treated with WBRT.
- Any intact BM size \> 3 cm. After surgical excision and appropriate radiation therapy to the cavity, patients may enroll if additional eligible lesions are present.
- Prior disease progression on one or more of the agents comprising SST.
- Exposure to one or more agents comprising SST within the last 30 days.
- Prior unacceptable toxicity during treatment with one or more agents comprising SST.
- people with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful...
- Skin Cancer Exclusion: Please note that localized cutaneous basal cell carcinoma and squamous cell carcinoma is not an exclusion criterion regardless of treatment status. Biopsy proven metastatic disease from these...
- Patient weight \>450 pounds.
- Patient had prior SRS to any intracranial lesion \<15mm from a metastasis on the screening MRI. Prior MRIs and DICOMs will be used to make this determination.
- Patient unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.
- Any BM with a significant hemorrhagic component (defined as MRI T1 intrinsic hyperintensity comprising ≥ 25% of maximal lesion diameter).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.