Brain MetastasesPhase 3NCT04365374
Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)
A Phase 3 study testing Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) and Stereotactic Radiation Therapy in people with Brain Metastases, run by GT Medical Technologies, Inc. at 37 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) and Stereotactic Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 37 sitesUnited States
- Study dates
- 6 Apr 2021to 30 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 six newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.
- Only one lesion, designated the index lesion, is planned for surgical resection. The index lesion must be between 2.0 and 7.0 cm in maximal extent on the screening MRI, 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) are 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.
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- Karnofsky Performance Scale (KPS) score of ≥ 70. Patients with KPS < 70 can be enrolled if their baseline KPS within 14 days of screening was estimated ≥ 70 and surgical management is expected to improve KPS to ≥ 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, Spanish, or another language the study site is prepared to obtain informed consent for in this trial. English speaking subjects will complete Neurocognitive assessments. Non-English-speaking subjects are trial-eligible but 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.
Who cannot join
- Age <18 years.
- Karnofsky Performance Scale (KPS) score of <70. Patients with KPS < 70 can be enrolled if their baseline KPS within 14 days of screening was estimated ≥ 70 and surgical management is expected to improve KPS to ≥ 70.
- Sensitivity to bovine (cow) derived materials including collagen products.
- Past radiation or surgical therapy to the index lesion or the newly diagnosed non-index lesion(s) is exclusionary. However, up to a total of 2 prior courses of SRT treatment to previously diagnosed lesions are allowed as long as any treated lesions are were ≥15mm from the index lesion.
- Patients with >6 newly diagnosed metastases on screening MRI
- Pregnant patients.
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- Primary germ cell tumor, small cell carcinoma, or lymphoma.
- Leptomeningeal metastasis (LMD). Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as radiologic or clinical evidence of leptomeningeal involvement with or without positive cerebrospinal fluid (CSF) cytology.
- Prior WBRT for brain metastases.
- Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Comorbid psychiatric or neurologic disease or injury impacting cognition, in the opinion of the treating physician, that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Albany Medical Center
Albany, New York, 12208
Piedmont Hospital
Atlanta, Georgia, 30309
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of North Carolina Health
Chapel Hill, North Carolina, 27599
RUSH University
Chicago, Illinois, 60607
Mayfield Brain and Spine
Cincinnati, Ohio, 45209
Ellis Fischel Cancer Center at University of Missouri
Columbia, Missouri, 65212
UT Southwestern Simmons Cancer Center
Dallas, Texas, 75235
Henry Ford Health
Detroit, Michigan, 48202
ECU Health
Greenville, North Carolina, 27834
Baylor St. Luke's Medical Center | Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist
Houston, Texas, 77030
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Indiana University, IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Ascension St. Vincent's- Riverside
Jacksonville, Florida, 32204
Baptist MD Anderson Cancer Center- Jacksonville
Jacksonville, Florida, 32207
The University Of Kansas Cancer Center
Kansas City, Kansas, 66016
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03766
University of Arkansas Medical Center
Little Rock, Arkansas, 72205
University of Louisville
Louisville, Kentucky, 40202
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
University Of Minnesota
Minneapolis, Minnesota, 55414
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Memorial Sloan Kettering
New York, New York, 10065
HCA Florida First Coast Neurology- Orange Park
Orange Park, Florida, 32073
Advent health Orlando
Orlando, Florida, 32804
Orlando Health
Orlando, Florida, 32806
HonorHeath Scottsdale Osborn Medical Center
Phoenix, Arizona, 85027
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Brown University Health
Providence, Rhode Island, 02906
UT Health San Antonio
San Antonio, Texas, 78249
Virginia Mason
Seattle, Washington, 98101
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, 33606
SCRI with Texas Oncology
The Woodlands, Texas, 77380
Westchester Medical Center
Westchester, New York, 10595
About this study
Official title: A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.
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.
Read the detailed description
GammaTile therapy results in improved clinical outcomes; however, the data is a single site experience with a limited number of subjects, including 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 GammaTile® (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 comparison 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 vs ≥60), duration of extracranial disease control (≤3 months vs >3 months), number of metastases (one, 2-4 total, 5-6 total ), histology (breast cancer, lung cancer, melanoma, other), the maximal diameter of the index lesion (≤3 cm, >3 cm to ≤5cm, >5cm to ≤7cm) and use of prior or current immunotherapy (yes vs no).
An index lesion meeting the criteria of ≥ 2.0-7.0 cm in maximum diameter and appropriate for gross total resection (GTR), will be identified and up to five (5) other unresected, previously untreated 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 guidelines (NCCN Guidelines, 2019). Additionally, all unresected, previously untreated 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 resection, and an intense but localized radiation treatment may confer a reduced risk for radiation necrosis compared to other therapies. It is typically easily placed with minimal additional operative time and limited staff radiation exposure.
Given these benefits, the rationale for conducting this randomized controlled 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.
- Conditions
- Brain Metastases
- Being tested
- Gamma Tile-Surgically Targeted Radiation Therapy (STaRT), Stereotactic Radiation Therapy
- Keywords
- Brain, Tumor, Cancer, New Diagnosis, Metastases, GammaTile, Radiation, Cs-131
- Medical subject headings
- Brain Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)Device
Also called Carrier Tile Brachytherapy Therapy (CTBT)
GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile
Stereotactic Radiation TherapyRadiation
External Beam Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Surgical Resection and GammaTile Therapy | Experimental | Surgical Resection and GammaTile Therapy Receives: Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) |
| Surgical Resection and Stereotactic Radiation Therapy | Active comparator | Surgical Resection and Stereotactic Radiation Therapy Receives: Radiation: Stereotactic Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical bed recurrence-free survival (SB-RFS) from the time of randomization up to 2 years post radiation.
Surgical bed control is defined as the absence of new nodular contrast enhancement in the index lesion surgical bed.
Measured: up to 2 years post-radiation
Secondary outcomes (7)
Overall Survival
Survival of subjects
Measured: up to 3 years
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
An assessment of quality of life (QOL)
Measured: up to 9 months
Linear Analog Scale Assessments (LASA)
An assessment of quality of life (QOL)
Measured: up to 9 months
Hopkins Verbal Learning Test (HVLT-R)
An assessment of neurocognitive status
Measured: up to 24 months
Controlled Oral Word Association Test (COWAT)
An assessment of neurocognitive status
Measured: up to 24 months
Trail Making Tests (TMT) Parts A and B
An assessment of neurocognitive status
Measured: up to 24 months
Barthel ADL
An assessment of physical functioning status
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start6 Apr 2021
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GT Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Weinberg, MD, Principal investigator, MD Anderson Cancer Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365374
- Sponsor's protocol ID
- GTM-102
- Status last verified
- Oct 2025
- First submitted
- 24 Apr 2020
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Weinberg J. Clinical Trials in Progress: ROADS Trial. Oncology (Williston Park). 2021 Aug 8;35(8):495. doi: 10.46883/ONC.2021.3508.0495.
PubMed 34398588
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.
- ClinicalTrials.gov ID
- NCT04365374
- Acronym / sponsor ID
- GTM-102
- Conditions
- Brain Metastases
- Keywords
- Brain, Tumor, Cancer, New Diagnosis, Metastases, GammaTile, Radiation, Cs-131
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- GT Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GammaTile therapy results in improved clinical outcomes; however, the data is a single site experience with a limited number of subjects, including 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 GammaTile® (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 comparison 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 vs ≥60), duration of extracranial disease control (≤3 months vs >3 months), number of metastases (one, 2-4 total, 5-6 total ), histology (breast cancer, lung cancer, melanoma, other), the maximal diameter of the index lesion (≤3 cm, >3 cm to ≤5cm, >5cm to ≤7cm) and use of prior or current immunotherapy (yes vs no).
An index lesion meeting the criteria of ≥ 2.0-7.0 cm in maximum diameter and appropriate for gross total resection (GTR), will be identified and up to five (5) other unresected, previously untreated 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 guidelines (NCCN Guidelines, 2019). Additionally, all unresected, previously untreated 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 resection, and an intense but localized radiation treatment may confer a reduced risk for radiation necrosis compared to other therapies. It is typically easily placed with minimal additional operative time and limited staff radiation exposure.
Given these benefits, the rationale for conducting this randomized controlled 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Resection and GammaTile Therapy | Experimental | Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)Surgical Resection and GammaTile Therapy |
| Surgical Resection and Stereotactic Radiation Therapy | Active comparator | Radiation: Stereotactic Radiation TherapySurgical Resection and Stereotactic Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 six newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.
- Only one lesion, designated the index lesion, is planned for surgical resection. The index lesion must be between 2.0 and 7.0 cm in maximal extent on the screening MRI, 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.
Key exclusion criteria (12 listed)
- Age <18 years.
- Karnofsky Performance Scale (KPS) score of <70. Patients with KPS < 70 can be enrolled if their baseline KPS within 14 days of screening was estimated ≥ 70 and surgical management is expected to improve KPS to ≥ 70.
- Sensitivity to bovine (cow) derived materials including collagen products.
- Past radiation or surgical therapy to the index lesion or the newly diagnosed non-index lesion(s) is exclusionary. However, up to a total of 2 prior courses of SRT treatment to previously diagnosed lesions are allowed as long as any treated lesions are were ≥15mm from the index lesion.
- Patients with >6 newly diagnosed metastases on screening MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)Also: Carrier Tile Brachytherapy Therapy (CTBT)GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile | Device | Surgical Resection and GammaTile Therapy |
| Stereotactic Radiation TherapyExternal Beam Radiation Therapy | Radiation | Surgical Resection and Stereotactic Radiation Therapy |
Primary outcome
Surgical bed recurrence-free survival (SB-RFS) from the time of randomization up to 2 years post radiation.
Time frame: up to 2 years post-radiation
Surgical bed control is defined as the absence of new nodular contrast enhancement in the index lesion surgical bed.
7 secondary outcomes
Overall Survival
Time frame: up to 3 years
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time frame: up to 9 months
Linear Analog Scale Assessments (LASA)
Time frame: up to 9 months
Hopkins Verbal Learning Test (HVLT-R)
Time frame: up to 24 months
Controlled Oral Word Association Test (COWAT)
Time frame: up to 24 months
Trail Making Tests (TMT) Parts A and B
Time frame: up to 24 months
Barthel ADL
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 34398588Weinberg J. Clinical Trials in Progress: ROADS Trial. Oncology (Williston Park). 2021 Aug 8;35(8):495. doi: 10.46883/ONC.2021.3508.0495.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Weinberg, MD principal investigator
MD Anderson Cancer Center, Houston, TX
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) and Stereotactic Radiation Therapy in people with Brain Metastases, run by GT Medical Technologies, Inc. at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical bed recurrence-free survival (SB-RFS) from the time of randomization up to 2 years post radiation. (time frame: up to 2 years post-radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.