SRT vs GammaTile Therapy for Brain Tumor
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: GT Medical Technologies, Inc.
Disqualifiers: Pregnancy, Leptomeningeal metastasis, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial allows for previous and concurrent treatment with certain medications, but there are specific timing restrictions around surgery and SRT. You may need to pause some medications around these procedures, so it's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment GammaTile Therapy for brain tumors?
GammaTile Therapy, a surgically targeted radiation therapy, is shown to be safe and effective for treating brain tumors, especially when combined with other standard treatments. It provides immediate, intense radiation after surgery, improving patient outcomes and reducing the need for frequent hospital visits.
12345Is GammaTile Therapy safe for treating brain tumors?
GammaTile Therapy, also known as Surgically Targeted Radiation Therapy (STaRT), has been shown to be safe in multiple clinical trials for treating both newly-diagnosed and recurrent brain tumors. It was approved by the FDA in 2018 for recurrent brain tumors and expanded to newly-diagnosed malignant brain tumors by 2020, indicating its safety profile in humans.
12345What makes GammaTile Therapy unique for treating brain tumors?
GammaTile Therapy is unique because it involves implanting a small, bioresorbable tile with radiation sources directly into the brain cavity after tumor removal, providing immediate and localized radiation treatment. This approach minimizes the need for frequent hospital visits and ensures consistent treatment, unlike traditional external radiation therapies.
12345Eligibility Criteria
Adults over 18 with 1-4 new brain metastases from another cancer, where one lesion is set for surgery and measures between 2.5cm to 5cm. Other lesions must be smaller than 4cm and not near critical areas like the optic chiasm or brainstem. Participants need a good performance status (KPS ≥70), expected to live at least six more months, able to undergo MRI with contrast, have proper kidney and liver function, use contraception if of childbearing potential, and understand English or Spanish.Inclusion Criteria
I have a brain lesion between 2.5 and 5.0 cm or a smaller one needing surgery.
I have 1-4 new brain tumors from cancer that started elsewhere.
I can sign or have someone legally authorized to sign for me the consent forms for this study.
+11 more
Exclusion Criteria
I am under 18 years old.
Pregnant patients
Patients with >4 newly diagnosed metastases on screening MRI
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgical Resection and Radiation Therapy
Participants undergo surgical resection followed by either GammaTile or Stereotactic Radiation Therapy
3-4 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 3 years
Regular visits as per study protocol
Long-term Follow-up
Participants are assessed for overall survival and quality of life
up to 3 years
Participant Groups
This study compares two treatments after surgical removal of certain brain tumors: GammaTile therapy given during surgery versus standard Stereotactic Radiation Therapy (SRT) done weeks later. It's a randomized trial which means patients are put into groups by chance.
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical Resection and GammaTile TherapyExperimental Treatment1 Intervention
Surgical Resection and GammaTile Therapy
Group II: Surgical Resection and Stereotactic Radiation TherapyActive Control1 Intervention
Surgical Resection and Stereotactic Radiation Therapy
Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) is already approved in United States for the following indications:
🇺🇸 Approved in United States as GammaTile Therapy for:
- Newly diagnosed malignant intracranial neoplasms
- Recurrent intracranial neoplasms
- Metastatic brain tumors
- Aggressive meningiomas
- High-grade gliomas
- Glioblastomas
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of LouisvilleLouisville, KY
University of Arkansas Medical CenterLittle Rock, AR
Virginia MasonSeattle, WA
UT Health San AntonioSan Antonio, TX
More Trial Locations
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Who Is Running the Clinical Trial?
GT Medical Technologies, Inc.Lead Sponsor
References
Clinical Trials in Progress: ROADS Trial. [2022]Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) versus Surgically Targeted Radiation Therapy (STaRT) with GammaTile for Treatment of Newly Diagnosed Metastatic Brain Tumors (ROADS; NCT04365374).
Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review. [2023]The mainstays of radiation therapy include external beam radiation therapy (EBRT) and internally implanted radiation, or brachytherapy (BT), all with distinct benefits and risks in terms of local or distant tumor control and normal brain toxicities, respectively. GammaTile® Surgically Targeted Radiation Therapy (STaRT) attempts to limit the drawbacks of other BT paradigms via a permanently implanted, bioresorbable, conformable, collagen tile containing four uniform intensity radiation sources, thus preventing deleterious direct contact with the brain and optimizing interseed spacing to homogenous radiation exposure. The safety and feasibility of GammaTile® STaRT therapy was established by multiple clinical trials encompassing the spectrum of primary and secondary brain neoplasms, both recurrent and newly-diagnosed. Implantable GT tiles were FDA approved in 2018 for use in recurrent intracranial neoplasms, expanded to newly-diagnosed malignant intracranial neoplasms by 2020. The current spectrum of trials focuses on better defining the relative efficacy and safety of non-GT standard-of-care radiation strategies for intracranial brain neoplasm. We summarize the key design and eligibility criteria for open and future trials of GT therapy, including registries and randomized trials for newly-diagnosed and recurrent brain metastases as well as recurrent and newly-diagnosed glioblastoma in combination with approved therapies.
Comprehensive Commissioning and Clinical Implementation of GammaTiles STaRT for Intracranial Brain Cancer. [2022]To validate the dose calculation accuracy and dose distribution of GammaTiles for brain tumors, and to suggest a surgically targeted radiation therapy (STaRT) workflow for planning, delivery, radiation safety documentation, and posttreatment validation.
GammaTile: Comprehensive Review of a Novel Radioactive Intraoperative Seed-Loading Device for the Treatment of Brain Tumors. [2022]GammaTile is a Food and Drug Administration (FDA)-licensed device consisting of four cesium-131 (Cs-131) radiation-emitting seeds in the collagen tile about the postage stamp size. The tiles are utilized to line the brain cavity immediately after tumor resection. GammaTile therapy is a surgically targeted radiation therapy (STaRT) that helps provide instant, dose-intense treatment after the completion of resection. The objective of this study is to explore the safety and efficacy of GammaTile surgically targeted radiation therapy for brain tumors. This study also reviews the differences between GammaTile surgically targeted radiation therapy (STaRT) and other traditional treatment options for brain tumors. The electronic database searches utilized in this study include PubMed, Google Scholar, and ScienceDirect. A total of 4,150 articles were identified based on the search strategy. Out of these articles, 900 articles were retrieved. A total of 650 articles were excluded for various reasons, thus retrieving 250 citations. We applied the exclusion and inclusion criteria to these retrieved articles by screening their full text and excluding 180 articles. Therefore, 70 citations were retrieved and included in this comprehensive literature review, as outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram. Based on the findings of this study, GammaTile surgically targeted radiation therapy (STaRT) is safe and effective for treating brain tumors. Similarly, the findings have also shown that the efficacy of GammaTile therapy can be enhanced by combining it with other standard-of-care treatment options/external beam radiation therapy (EBRT). Also, the results show that patients diagnosed with recurrent glioblastoma (GBM) exhibit poor median overall survival because of the possibility of the tumor returning. Therefore, combining STaRT with other standard-of-care treatment options/EBRT can improve the patient's overall survival (OS). GammaTile therapy enhances access to care, guarantees 100% compliance, and eliminates patients' need to travel regularly to hospitals for radiation treatments. Its implementation requires collaboration from various specialties, such as radiation oncology, medical physics, and neurosurgery.
GammaTile® brachytherapy in the treatment of recurrent glioblastomas. [2022]GammaTile® (GT) is a recent U.S. Food and Drug Administration (FDA) cleared brachytherapy platform. Here, we report clinical outcomes for recurrent glioblastoma patients after GT treatment following maximal safe resection.