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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Vinai Gondi
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR