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Spots Global Cancer Trial Database for Testing the Addition of Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in People With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery

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Trial Identification

Brief Title: Testing the Addition of Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in People With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery

Official Title: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

Study ID: NCT04588246

Study Description

Brief Summary: This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on thinking and memory. Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery may be effective in shrinking or stabilizing cancer that has spread to the brain and returned in other areas of the brain after receiving stereotactic radiosurgery.

Detailed Description: PRIMARY OBJECTIVE: I. To determine if salvage stereotactic radiosurgery (SRS) plus whole brain radiotherapy with hippocampal avoidance (HA-WBRT) in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS prolongs time to neurologic death as compared to salvage SRS alone. SECONDARY OBJECTIVES: I. To determine if salvage SRS + HA-WBRT in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS prolongs overall survival as compared to salvage SRS alone. II. To evaluate if salvage SRS + HA-WBRT in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS prolongs intracranial progression-free survival as compared to salvage SRS alone. III. To evaluate if salvage SRS + HA-WBRT in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS improves brain metastasis velocity at subsequent relapse as compared to salvage SRS alone. IV. To assess perceived difficulties in cognitive abilities, symptom burden and health status after salvage SRS + HA-WBRT, as compared to salvage SRS alone, in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS. V. To compare neurocognitive function outcomes following salvage SRS + HA-WBRT, as compared to salvage SRS alone, in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS. VI. To tabulate and descriptively compare the adverse events associated with the interventions. VII. To tabulate and descriptively compare the number of salvage procedures used to manage recurrent intracranial disease following the interventions. EXPLORATORY OBJECTIVES: I. To collect serum, plasma, and whole blood for translational research analyses. II. To collect baseline and all follow-up magnetic resonance (MR) imaging for hippocampal volume, memory center substructures, axial T2 volumes, and quantitative texture analysis. III. To collect baseline and follow-up MR imaging to extract whole brain volume, white matter volume and volume of metastatic disease to correlate with cognitive change at 4 months. IV. To evaluate dose-volume histogram parameters to correlate with radiation toxicity. V. To assess in patients receiving immunotherapy or targeted therapy, if salvage SRS + HA-WBRT in patients with brain metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS improves brain metastasis velocity and/or overall survival at subsequent relapse as compared to salvage SRS. VI. To compare the estimated cost of brain-related therapies and quality-adjusted life years in patients who receive salvage SRS + HA-WBRT, as compared to salvage SRS alone, in patients with metastasis velocity \>= 4 new brain metastases/year at time of first or second distant brain failure following upfront SRS. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total of 10 fractions in the absence of disease progression or unacceptable toxicity. Within 1 week prior to or following HA-WBRT, patients undergo salvage SRS. Prior to HA-WBRT or no later than the 4th treatment, patients also receive memantine orally (PO) once daily (QD) or twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo salvage SRS. After completion of study treatment, patients are followed up every 2-3 months for at least 1 year.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Banner University Medical Center - Tucson, Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States

City of Hope Corona, Corona, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

City of Hope at Irvine Lennar, Irvine, California, United States

City of Hope Antelope Valley, Lancaster, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States

Sutter Roseville Medical Center, Roseville, California, United States

Sutter Medical Center Sacramento, Sacramento, California, United States

City of Hope South Pasadena, South Pasadena, California, United States

City of Hope South Bay, Torrance, California, United States

City of Hope Upland, Upland, California, United States

Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States

Helen F Graham Cancer Center, Newark, Delaware, United States

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

Mayo Clinic in Florida, Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

Memorial Hospital West, Pembroke Pines, Florida, United States

Northwestern University, Chicago, Illinois, United States

Rush University Medical Center, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Carle at The Riverfront, Danville, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

The Carle Foundation Hospital, Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center, Bel Air, Maryland, United States

Central Maryland Radiation Oncology in Howard County, Columbia, Maryland, United States

UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie, Maryland, United States

Tufts Medical Center, Boston, Massachusetts, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States

Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Siteman Cancer Center-South County, Saint Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States

Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States

University of Rochester, Rochester, New York, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Sanford Bismarck Medical Center, Bismarck, North Dakota, United States

Sanford Broadway Medical Center, Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States

Riddle Memorial Hospital, Media, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States

Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States

Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States

Lankenau Medical Center, Wynnewood, Pennsylvania, United States

UPMC Memorial, York, Pennsylvania, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States

Covenant Medical Center-Lakeside, Lubbock, Texas, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Drexel Town Square Health Center, Oak Creek, Wisconsin, United States

Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend, Wisconsin, United States

Contact Details

Name: Vinai Gondi

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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