ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2021-04-06

Study Completion:2029-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04365374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jeffrey Weinberg, MD

PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center, Houston, TX

Study Locations (Sites)

HonorHeath Scottsdale Osborn Medical Center

Phoenix, Arizona, 85027

United States

University of Arkansas Medical Center

Little Rock, Arkansas, 72205

United States

Ascension St. Vincent's- Riverside

Jacksonville, Florida, 32204

United States

Baptist MD Anderson Cancer Center- Jacksonville

Jacksonville, Florida, 32207

United States

HCA Florida First Coast Neurology- Orange Park

Orange Park, Florida, 32073

United States

Advent health Orlando

Orlando, Florida, 32804

United States

Orlando Health

Orlando, Florida, 32806

United States

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

Tampa, Florida, 33606

United States

Piedmont Hospital

Atlanta, Georgia, 30309

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

United States

RUSH University

Chicago, Illinois, 60607

United States

Indiana University, IU Health Methodist Hospital

Indianapolis, Indiana, 46202

United States

The University Of Kansas Cancer Center

Kansas City, Kansas, 66016

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Henry Ford Health

Detroit, Michigan, 48202

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

University Of Minnesota

Minneapolis, Minnesota, 55414

United States

Ellis Fischel Cancer Center at University of Missouri

Columbia, Missouri, 65212

United States

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110

United States

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766

United States

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, 07753

United States

Albany Medical Center

Albany, New York, 12208

United States

Memorial Sloan Kettering

New York, New York, 10065

United States

Westchester Medical Center

Westchester, New York, 10595

United States

University of North Carolina Health

Chapel Hill, North Carolina, 27599

United States

ECU Health

Greenville, North Carolina, 27834

United States

Mayfield Brain and Spine

Cincinnati, Ohio, 45209

United States

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212

United States

Brown University Health

Providence, Rhode Island, 02906

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

UT Southwestern Simmons Cancer Center

Dallas, Texas, 75235

United States

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

Houston, Texas, 77030

United States

Houston Methodist

Houston, Texas, 77030

United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

UT Health San Antonio

San Antonio, Texas, 78249

United States

SCRI with Texas Oncology

The Woodlands, Texas, 77380

United States

Virginia Mason

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: GT Medical Technologies, Inc.

Jeffrey Weinberg, MD, PRINCIPAL_INVESTIGATOR, MD Anderson Cancer Center, Houston, TX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-06

Study Completion Date2029-08-30

Study Record Updates

Study Start Date2021-04-06

Study Completion Date2029-08-30

Terms related to this study

Keywords Provided by Researchers

Brain
Tumor
Cancer
New Diagnosis
Metastases
GammaTile
Radiation
Cs-131

Additional Relevant MeSH Terms

Brain Metastases