Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

NCT04365374 | Active Not Recruiting Phase 3 DMC FDA Device

• 1 other identifier: GTM-102
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Brain Metastases

Keywords

Brain; Tumor; Cancer; New Diagnosis; Metastases; GammaTile; Radiation; Cs-131

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 years post-radiation

Secondary Outcomes (7)

• Overall Survival

  up to 3 years

• Functional Assessment of Cancer Therapy-Brain (FACT-Br)

  up to 9 months

• Linear Analog Scale Assessments (LASA)

  up to 9 months

• Hopkins Verbal Learning Test (HVLT-R)

  up to 24 months

• Controlled Oral Word Association Test (COWAT)

  up to 24 months

Study Arms (2)

Surgical Resection and GammaTile Therapy

EXPERIMENTAL

Surgical Resection and GammaTile Therapy

Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)

Surgical Resection and Stereotactic Radiation Therapy

ACTIVE COMPARATOR

Surgical Resection and Stereotactic Radiation Therapy

Radiation: Stereotactic Radiation Therapy

Interventions

Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) DEVICE

GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile

Also known as: Carrier Tile Brachytherapy Therapy (CTBT)

Surgical Resection and GammaTile Therapy

Stereotactic Radiation Therapy RADIATION

External Beam Radiation Therapy

Surgical Resection and Stereotactic Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Patients with \>6 newly diagnosed metastases on screening MRI
• Pregnant patients.
• Primary germ cell tumor, small cell carcinoma, or lymphoma.
• 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.

Sponsors & Collaborators

• GT Medical Technologies, Inc.: lead

Study Sites (37)

HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona, 85027, United States

Location

University of Arkansas Medical Center

Little Rock, Arkansas, 72205, United States

Location

Ascension St. Vincent's- Riverside

Jacksonville, Florida, 32204, United States

Location

Baptist MD Anderson Cancer Center- Jacksonville

Jacksonville, Florida, 32207, United States

Location

HCA Florida First Coast Neurology- Orange Park

Orange Park, Florida, 32073, United States

Location

Advent health Orlando

Orlando, Florida, 32804, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

RUSH University

Chicago, Illinois, 60607, United States

Location

Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

The University Of Kansas Cancer Center

Kansas City, Kansas, 66016, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

University Of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Ellis Fischel Cancer Center at University of Missouri

Columbia, Missouri, 65212, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States

Location

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

Westchester Medical Center

Westchester, New York, 10595, United States

Location

University of North Carolina Health

Chapel Hill, North Carolina, 27599, United States

Location

ECU Health

Greenville, North Carolina, 27834, United States

Location

Mayfield Brain and Spine

Cincinnati, Ohio, 45209, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Brown University Health

Providence, Rhode Island, 02906, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Simmons Cancer Center

Dallas, Texas, 75235, United States

Location

Baylor St. Luke's Medical Center | Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UT Health San Antonio

San Antonio, Texas, 78249, United States

Location

SCRI with Texas Oncology

The Woodlands, Texas, 77380, United States

Location

Virginia Mason

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Weinberg J. Clinical Trials in Progress: ROADS Trial. Oncology (Williston Park). 2021 Aug 8;35(8):495. doi: 10.46883/ONC.2021.3508.0495.

  PMID: 34398588 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeffrey Weinberg, MD

  MD Anderson Cancer Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: April 6, 2021
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): August 30, 2029
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)