Post-Surgical SRT Versus STaRT with Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors

This is a Phase 3 clinical trial that will be taking place at our clinic. This study aims to explore the effectiveness of different treatments for newly diagnosed brain metastasis.

The trial will enroll adults aged 18 years and above who meet the specific inclusion and exclusion criteria. The trial will be comparing two treatment methods: surgical tumor removal followed by stereotactic radiotherapy (SRT), and surgical tumor removal followed by intraoperative radiation therapy using GammaTilesTM (Radiation).

The study will take place at up to 20 clinical sites, and participants will be randomly assigned to one of the treatment groups. This is a prospective, randomized, parallel group, open-label, and multi-site.

The primary outcome measure will be focused on the intent to treat population, and the primary endpoint will be the surgical bed control. Simply put, the rial will be assessing the recurrence-free survival (SB-RFS) of the surgical bed, which is determined by the absence of new or enlarging nodular contrast enhancement within the surgical bed. This assessment will be tracked from the time of randomization until the occurrence of a SB-RFS event. A SB-RFS event is defined as radiographic evidence of a new or progressive contrast-enhancing lesion within the site of the surgical resection, as determined by RANO-BM criterion. Importantly, this event should not coincide with a postoperative diffusion weighted imaging (DWI). For clarity, this trial will be using cross-sectional MRI images (coronal, axial, and sagittal) to document any failures that support this endpoint.

The results will significantly contribute to the advancement of treatment options for patients with brain metastasis.

In order to participate you must meet the following criteria:

• Are 18 years of age or older. Eligibility is restricted to this age group given that the battery of neurocognitive tests utilized in this protocol are not developed or validated for use in a younger population.
• Have one to four newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.
• Have only one lesion, designated the index lesion, is planned for surgical resection and is to be between 2.5 cm and 5.0 cm on the screening MRI, and gross total resection is expected. Index lesions > 2.0 cm but <2.5 cm are also eligible if surgery is deemed clinically necessary and gross total resection is expected by the neurosurgeon.
• Non-index lesions must measure < 4.0 cm in maximal extent on the screening MRI brain scan. The unresected lesions will be treated with SRT as outlined in the treatment section of the concept.
• All metastases must be located > 5 mm from the optic chiasm and outside the brainstem. Dural based metastasis are eligible.
• Previous and/or concurrent treatment with investigational or FDA approved systemic therapies (e.g., chemotherapy, targeted therapeutics, immunotherapy) is permitted and must follow protocol guidelines as follows: Systemic therapy is allowed a minimum of one week from last systemic therapy cycle to surgical resection, and one week after surgical resection to allow a minimum of one week before starting/resuming systemic therapy, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Systemic therapy is not allowed 1 day before SRT, the same day as the SRT, or 1 day after the completion of the SRT or longer, depending on the specific systemic agent(s), as recommended by medical/neuro-oncology. Agents that are delivered by implant or depot injections (such as hormonal therapies) are excluded from these restrictions.
• Have a KPS score of ≥70. (may be obtained from medical records within 14 days of screening if not performed at screening).
• Have stable systemic disease or reasonable systemic treatment options predicting a life expectancy of ≥6 months.
• Have the ability to complete an MRI of the head with contrast
• Have adequate renal and hepatic function to undergo surgery, in investigators opinion.
• For women of childbearing potential only, a negative urine or serum pregnancy test done < 7 days prior to randomization is required. Women must be willing to notify investigator immediately if they become pregnant at any time during the trial period.
• Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
• Are fluent in the English language to allow for completion of neurocognitive tests and completion of QOL questionnaires. Non-English speaking subjects are not permitted to participate given that participation in the real time integrated neurocognitive function tests is mandatory for all patients. The psychometric properties for translated tests are either not known or not as robust.
• Are willing and able to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.