Ireland
--:--IST
Active, not recruiting Phase 3

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

NCT04365374 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2021-04-06
Last updated
2025-10-07

Condition(s) studied

Brain Metastases

Investigational drug(s) / intervention(s)

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

Gamma Tile-Surgically Targeted Radiation Therapy (STaRT): GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile

Stereotactic Radiation Therapy: External Beam Radiation Therapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Surgical bed recurrence-free survival (SB-RFS) from the time of randomization up to 2 years post radiation. — 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.

Trial sites (37)

FacilityCityRegionStatus
HonorHeath Scottsdale Osborn Medical Center Phoenix Arizona
University of Arkansas Medical Center Little Rock Arkansas
Ascension St. Vincent's- Riverside Jacksonville Florida
Baptist MD Anderson Cancer Center- Jacksonville Jacksonville Florida
HCA Florida First Coast Neurology- Orange Park Orange Park Florida
Advent health Orlando Orlando Florida
Orlando Health Orlando Florida
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital Tampa Florida
Piedmont Hospital Atlanta Georgia
Winship Cancer Institute of Emory University Atlanta Georgia
RUSH University Chicago Illinois
Indiana University, IU Health Methodist Hospital Indianapolis Indiana
The University Of Kansas Cancer Center Kansas City Kansas
University of Louisville Louisville Kentucky
Henry Ford Health Detroit Michigan
Abbott Northwestern Hospital Minneapolis Minnesota
University Of Minnesota Minneapolis Minnesota
Ellis Fischel Cancer Center at University of Missouri Columbia Missouri
SSM Health Saint Louis University Hospital St Louis Missouri
Dartmouth-Hitchcock Lebanon New Hampshire
HMH Jersey Shore University Medical Center Neptune City New Jersey
Albany Medical Center Albany New York
Memorial Sloan Kettering New York New York
Westchester Medical Center Westchester New York
University of North Carolina Health Chapel Hill North Carolina
ECU Health Greenville North Carolina
Mayfield Brain and Spine Cincinnati Ohio
Allegheny Health Network Pittsburgh Pennsylvania
Brown University Health Providence Rhode Island
Vanderbilt University Medical Center Nashville Tennessee
UT Southwestern Simmons Cancer Center Dallas Texas
Baylor St. Luke's Medical Center | Baylor College of Medicine Houston Texas
Houston Methodist Houston Texas
The University of Texas M. D. Anderson Cancer Center Houston Texas
UT Health San Antonio San Antonio Texas
SCRI with Texas Oncology The Woodlands Texas
Virginia Mason Seattle Washington

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04365374 on ClinicalTrials.gov ↗ ← All trials in the USA