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

NCT ID: NCT04365374

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2029-08-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical Resection and GammaTile Therapy

Surgical Resection and GammaTile Therapy

Group Type: EXPERIMENTAL

Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)

Intervention Type: DEVICE

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

Surgical Resection and Stereotactic Radiation Therapy

Surgical Resection and Stereotactic Radiation Therapy

Group Type: ACTIVE_COMPARATOR

Stereotactic Radiation Therapy

Intervention Type: RADIATION

External Beam Radiation Therapy

Interventions

Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)

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

Intervention Type: DEVICE

Stereotactic Radiation Therapy

External Beam Radiation Therapy

Intervention Type: RADIATION

Other Intervention Names

Carrier Tile Brachytherapy Therapy (CTBT)

Eligibility Criteria

Inclusion Criteria

1. 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.

2. One to six newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.

3. 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.

4. 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.

5. All metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem. Dural based metastasis are eligible.

6. 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.

7. 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.

8. Stable systemic disease or reasonable systemic treatment options predicting a life expectancy of ≥6 months.

9. Ability to complete an MRI of the head with contrast

10. Adequate renal and hepatic function to undergo surgery, in investigators opinion.

11. 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.

12. 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.

13. 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.

14. 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.

Exclusion Criteria

1. Age <18 years.

2. 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.

3. Sensitivity to bovine (cow) derived materials including collagen products.

4. 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.

5. Patients with >6 newly diagnosed metastases on screening MRI

6. Pregnant patients.

7. Primary germ cell tumor, small cell carcinoma, or lymphoma.

8. 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.

9. Prior WBRT for brain metastases.

10. Concomitant therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.

11. 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

12. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GT Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Weinberg, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center, Houston, TX

Locations

HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona, United States

University of Arkansas Medical Center

Little Rock, Arkansas, United States

Ascension St. Vincent's- Riverside

Jacksonville, Florida, United States

Baptist MD Anderson Cancer Center- Jacksonville

Jacksonville, Florida, United States

HCA Florida First Coast Neurology- Orange Park

Orange Park, Florida, United States

Advent health Orlando

Orlando, Florida, United States

Orlando Health

Orlando, Florida, United States

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

Tampa, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

RUSH University

Chicago, Illinois, United States

Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana, United States

The University Of Kansas Cancer Center

Kansas City, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Henry Ford Health

Detroit, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

University Of Minnesota

Minneapolis, Minnesota, United States

Ellis Fischel Cancer Center at University of Missouri

Columbia, Missouri, United States

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Memorial Sloan Kettering

New York, New York, United States

Westchester Medical Center

Westchester, New York, United States

University of North Carolina Health

Chapel Hill, North Carolina, United States

ECU Health

Greenville, North Carolina, United States

Mayfield Brain and Spine

Cincinnati, Ohio, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Brown University Health

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Simmons Cancer Center

Dallas, Texas, United States

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

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

SCRI with Texas Oncology

The Woodlands, Texas, United States

Virginia Mason

Seattle, Washington, United States

Countries

United States

References

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

Reference Type: DERIVED

PMID: 34398588 (View on PubMed)

Other Identifiers

GTM-102

Identifier Type: -

Identifier Source: org_study_id