SRT vs GammaTile Therapy for Brain Tumor

Recruiting at 45 trial locations

Overseen By John Floyd, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GT Medical Technologies, Inc.

Disqualifiers: Pregnancy, Leptomeningeal metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

180 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 5}

What 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. ^{1 2 3 4 5}

Research Team

Jeffrey Weinberg, MD

Principal Investigator

MD Anderson Cancer Center, Houston, TX

Eligibility 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.

Exclusion Criteria

I am under 18 years old.

Pregnant patients

Patients with >4 newly diagnosed metastases on screening MRI

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

Treatment Details

Interventions

• Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)
• Stereotactic Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: Surgical Resection and GammaTile Therapy Experimental Treatment 1 Intervention

Surgical Resection and GammaTile Therapy

Group II: Surgical Resection and Stereotactic Radiation Therapy Active Control 1 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

Who Is Running the Clinical Trial?

GT Medical Technologies, Inc.

Lead Sponsor

Trials

6

Recruited

1,700+

Findings from Research

The ROADS trial is a Phase 3 randomized controlled study comparing the effectiveness of post-surgical stereotactic radiotherapy (SRT) to surgically targeted radiation therapy (STaRT) using GammaTile for patients with newly diagnosed metastatic brain tumors.

This trial aims to determine which treatment method provides better outcomes in terms of safety and efficacy for patients undergoing surgery for metastatic brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials in Progress: ROADS Trial. Weinberg, J.[2022]

GammaTile® Surgically Targeted Radiation Therapy (STaRT) offers a novel approach to brain tumor treatment by using a bioresorbable tile that delivers radiation while minimizing direct contact with brain tissue, which helps reduce normal brain toxicity.

This therapy has been FDA approved since 2018 for recurrent brain tumors and expanded in 2020 to include newly-diagnosed malignant tumors, with ongoing trials aimed at comparing its efficacy and safety against standard radiation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review. Odia, Y., Gutierrez, AN., Kotecha, R.[2023]

GammaTiles, which use Cs-131 isotopes embedded in collagen, demonstrated high accuracy in dose calculation for brain tumors, achieving less than 0.5% error in most cases, indicating their reliability for targeted radiation therapy.

The study established a comprehensive workflow for the safe implantation of GammaTiles, emphasizing the need for thorough preplanning and interdisciplinary collaboration to ensure effective treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Commissioning and Clinical Implementation of GammaTiles STaRT for Intracranial Brain Cancer. Penoncello, GP., Gagneur, JD., Vora, SA., et al.[2022]

GammaTile therapy, a surgically targeted radiation treatment using cesium-131 seeds, has been found to be safe and effective for treating brain tumors, as supported by a comprehensive review of 70 studies.

Combining GammaTile therapy with standard treatments like external beam radiation therapy can improve overall survival rates for patients with recurrent glioblastoma, addressing the challenge of tumor recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GammaTile: Comprehensive Review of a Novel Radioactive Intraoperative Seed-Loading Device for the Treatment of Brain Tumors. Ekhator, C., Nwankwo, I., Rak, E., et al.[2022]

In a study of 22 patients with recurrent glioblastoma treated with GammaTile® brachytherapy after surgery, the treatment showed promising local control rates of 86% at six months and 81% at twelve months, indicating its efficacy in managing tumor recurrence.

The safety profile was acceptable, with only one case of 30-day mortality and a low rate of complications, suggesting that GammaTile® can be a viable option in the multi-modality treatment of recurrent glioblastomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GammaTile® brachytherapy in the treatment of recurrent glioblastomas. Gessler, DJ., Neil, EC., Shah, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Trials in Progress: ROADS Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Commissioning and Clinical Implementation of GammaTiles STaRT for Intracranial Brain Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

GammaTile: Comprehensive Review of a Novel Radioactive Intraoperative Seed-Loading Device for the Treatment of Brain Tumors. [2022]

5. England pubmed.ncbi.nlm.nih.gov

GammaTile® brachytherapy in the treatment of recurrent glioblastomas. [2022]