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.

Who is this study for? Adult patients with Brain Tumors
What treatments are being studied? Gamma Tile Surgically-Targeted Radiotherapy
Status: Active_not_recruiting
Location: See all (37) locations...
Intervention Type: Device, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
University of Arkansas Medical Center
Little Rock
Arizona
HonorHeath Scottsdale Osborn Medical Center
Phoenix
Florida
Ascension St. Vincent's- Riverside
Jacksonville
Baptist MD Anderson Cancer Center- Jacksonville
Jacksonville
HCA Florida First Coast Neurology- Orange Park
Orange Park
Advent health Orlando
Orlando
Orlando Health
Orlando
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa
Georgia
Piedmont Hospital
Atlanta
Winship Cancer Institute of Emory University
Atlanta
Illinois
RUSH University
Chicago
Indiana
Indiana University, IU Health Methodist Hospital
Indianapolis
Kansas
The University Of Kansas Cancer Center
Kansas City
Kentucky
University of Louisville
Louisville
Michigan
Henry Ford Health
Detroit
Minnesota
Abbott Northwestern Hospital
Minneapolis
University Of Minnesota
Minneapolis
Missouri
Ellis Fischel Cancer Center at University of Missouri
Columbia
SSM Health Saint Louis University Hospital
St Louis
North Carolina
University of North Carolina Health
Chapel Hill
ECU Health
Greenville
New Hampshire
Dartmouth-Hitchcock
Lebanon
New Jersey
HMH Jersey Shore University Medical Center
Neptune City
New York
Albany Medical Center
Albany
Memorial Sloan Kettering
New York
Westchester Medical Center
Westchester
Ohio
Mayfield Brain and Spine
Cincinnati
Pennsylvania
Allegheny Health Network
Pittsburgh
Rhode Island
Brown University Health
Providence
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
UT Southwestern Simmons Cancer Center
Dallas
Baylor St. Luke's Medical Center | Baylor College of Medicine
Houston
Houston Methodist
Houston
The University of Texas M. D. Anderson Cancer Center
Houston
UT Health San Antonio
San Antonio
SCRI with Texas Oncology
The Woodlands
Washington
Virginia Mason
Seattle
Time Frame
Start Date: 2021-04-06
Completion Date: 2029-08-30
Participants
Target number of participants: 230
Treatments
Experimental: Surgical Resection and GammaTile Therapy
Surgical Resection and GammaTile Therapy
Active_comparator: Surgical Resection and Stereotactic Radiation Therapy
Surgical Resection and Stereotactic Radiation Therapy
Related Therapeutic Areas
Sponsors
Leads: GT Medical Technologies, Inc.

This content was sourced from clinicaltrials.gov