SRT vs GammaTile Therapy for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare two types of radiation treatments for brain tumors that have spread from other parts of the body. One group will receive GammaTile Therapy, a type of radiation applied during surgery, while the other group will receive Stereotactic Radiation Therapy (SRT), typically administered a few weeks after surgery. The trial targets individuals with one to six new brain metastases from another primary cancer and a specific tumor planned for surgical removal. Participants should not have had prior radiation or surgery to the targeted tumor and must be able to undergo an MRI scan. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both GammaTile Therapy and Stereotactic Radiation Therapy (SRT) are generally safe for individuals considering a clinical trial.
Research indicates that GammaTile Therapy is usually safe and effective for treating brain tumors. The treatment targets precisely, helping to protect healthy brain tissue. The FDA has approved it for patients with both new and recurring malignant brain tumors, suggesting safety, though individual experiences may vary.
Stereotactic Radiation Therapy is also well-tolerated. Studies have found it effectively controls tumors with few side effects. The treatment focuses on the tumor, minimizing harm to nearby healthy tissue.
In summary, both treatments have demonstrated promising safety records in studies, with targeted approaches that aim to protect healthy tissue. However, as with any medical treatment, risks may exist, and individual experiences can differ.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GammaTile Therapy for brain tumors because it offers a novel way to deliver radiation directly to the tumor site. Unlike traditional methods where radiation is delivered externally over several sessions, GammaTile involves implanting small, tile-like devices during surgery that emit radiation precisely where it's needed. This targeted approach can help protect healthy brain tissue from radiation exposure, potentially reducing side effects and allowing for a more concentrated dose to the tumor. Meanwhile, Stereotactic Radiation Therapy (SRT) is already known for its precision, but it is delivered externally and requires multiple sessions. By comparing these methods, researchers hope to discover which approach is more effective and safer for patients with brain tumors.
What evidence suggests that this trial's treatments could be effective for brain tumors?
This trial will compare Surgical Resection combined with GammaTile Therapy to Surgical Resection combined with Stereotactic Radiation Therapy (SRT) for treating brain tumors. Research has shown that GammaTile Therapy effectively treats brain tumors. In one study, 80% of patients with brain metastases treated with GammaTile experienced no tumor regrowth within a year. Another study found that patients using GammaTile lived longer without tumor recurrence and had over a 50% lower risk of tumor growth.
Stereotactic Radiation Therapy (SRT) is another strong option in this trial. Research suggests that SRT provides similar survival outcomes for patients with up to 10 brain metastases as it does for those with fewer. SRT precisely targets tumors, helping to protect nearby healthy brain tissue. Both treatments have shown promising results, but GammaTile might offer a better chance of preventing tumor regrowth.56789Who Is on the Research Team?
Jeffrey Weinberg, MD
Principal Investigator
MD Anderson Cancer Center, Houston, TX
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Resection and Radiation Therapy
Participants undergo surgical resection followed by either GammaTile or Stereotactic Radiation Therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are assessed for overall survival and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)
- Stereotactic Radiation Therapy
Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) is already approved in United States for the following indications:
- Newly diagnosed malignant intracranial neoplasms
- Recurrent intracranial neoplasms
- Metastatic brain tumors
- Aggressive meningiomas
- High-grade gliomas
- Glioblastomas
Find a Clinic Near You
Who Is Running the Clinical Trial?
GT Medical Technologies, Inc.
Lead Sponsor