Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)
Brain & Spinal Cord Tumor
Unknown Primary
18 Years and older, Male and Female
GTM-102 (primary)
NCI-2021-03480
Summary
This trial will be a randomized controlled study comparing the efficacy and safety of
intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following
metastatic tumor resection which is the current standard of care.
Objectives
GammaTile therapy results in improved clinical outcomes; however the data is a single
site experience with a limited number of subjects, only 12 of which were patients with
metastatic brain tumors. The primary objective of this randomized, controlled trial is to
compare the efficacy and safety of intraoperative radiation therapy using GammaTilesTM
(GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current
standard of care. The data collected in this trial design will allow for a direct
comparisons of a variety of outcomes including local control, overall survival,
functional status, quality of life, neurocognitive status and safety in the target
population. In order to support direct comparisons, subjects will be randomized to the
two equally sized arms (1:1) based on the following stratification factors; age (<60 and
=60), duration of extracranial disease control (=3 months vs >3 months), number of
metastases (one vs multiple), histology (lung and radiation resistant), and the maximal
diameter of the index lesion (=3 cm and >3 cm) and use of prior or current immunotherapy
(yes vs no).
An index lesion meeting the criteria of = 2.5cm in maximum diameter and appropriate for
gross total resection (GTR), will be identified and up to three other non-resectable
lesions in a patient will be allowed. After resection of the index lesion, the surgical
bed will be treated with adjunct radiation (either GT or SRT) thereby following the
standard of care guideline. (NCCN Guidelines, 2019). Additional, unresected metastatic
lesions will be treated with stereotactic radiosurgery alone, which also adheres to
standard of care guidelines (NCCN Guidelines, 2019).
GammaTile is an FDA-cleared means of rapid dose delivery of radiation therapy directly to
the tumor bed with predictable dosimetry at the immediate time of re-resection, and a
intense but localized radiation treatment may confer a reduced risk for radiation
necrosis compared to other therapies. It is typically easly placed with minimal
additional operative time and limited staff radiation exposure.
Given these benefits, the rationale for conducting this randomized control comparison
study is to generate additional data, to further support the use of this new FDA-cleared
method of delivering radiation therapy in the setting of newly diagnosed brain
metastases.
Eligibility
- Patients aged 18 years old and above. 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.
- One to four newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.
- 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. Index lesions =2.0 cm but <2.5 cm are also eligible if surgery is deemed clinically necessary and appropriate for an attempted gross total resection 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.
- KPS score of =70.
- Stable systemic disease or reasonable systemic treatment options predicting a life expectancy of =6 months.
- Ability to complete an MRI of the head with contrast
- 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.
- Subjects must be fluent in English or Spanish language. English speaking subjects will complete Neurocognitive assessments. Non-English speaking subjects will not complete the Neurocognitive assessments as the psychometric properties for translated tests are either not known or not as robust.
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.
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