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Brief Title: Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability
Official Title: Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or Fewer Brain Metastases From Small Cell Lung Cancer
Study ID: NCT04804644
Brief Summary: This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.
Detailed Description: PRIMARY OBJECTIVE: I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test - Revised (HVLT-R), Controlled Oral Word Association (COWA) test, and the Trail Making Test (TMT). SECONDARY OBJECTIVES: I. Determine whether SRS relative to HA-WBRT plus memantine for brain metastases from SCLC preserves cognitive function as separately measured by the HVLT-R, COWA, TMT Parts A and B, and Clinical Trial Battery Composite (CTB COMP). II. Assess perceived difficulties in cognitive abilities using Patient Reported Outcomes Measurement Information System (PROMIS) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. III. Assess symptom burden using the MD Anderson Symptom Inventory for brain tumor (MDASI-BT) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. IV. Compare cumulative incidence of intracranial disease progression after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. V. Compare overall survival after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. VI. Compare cumulative incidence of neurologic death after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. VII. Compare the number of salvage procedures used to manage recurrent intracranial disease following SRS relative to HA-WBRT plus memantine for SCLC brain metastases. VIII. Compare adverse events between the treatment arms according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. IX. Compare the risk of developing cerebral necrosis between SRS and HA-WBRT plus memantine in patients receiving concurrent immunotherapy. EXPLORATORY OBJECTIVES: I. Compare cumulative incidence of local brain recurrence, distant brain relapse, and leptomeningeal dissemination after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. II. Compare the cost of brain-related therapies and quality-adjusted life years in patients who receive SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. III. Evaluate the time delay to salvage WBRT or HA-WBRT in patients enrolled on the SRS arm. IV. Evaluate whether a time delay for chemotherapy in patients receiving HA-WBRT plus memantine relative to SRS for brain metastases from SCLC has an effect on overall survival. V. Evaluate baseline magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. VI. Evaluate the correlation between neurocognitive functioning and patient-reported outcomes. VII. Collect serum, plasma and imaging studies for future translational research analyses. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SRS over 1 day (in some cases several days). ARM II: Patients undergo HA-WBRT once daily (QD) for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive memantine orally (PO) QD or twice daily (BID) for up to 24 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months for 1 year, and then every 6 months thereafter.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
UCHealth Memorial Hospital Central, Colorado Springs, Colorado, United States
Memorial Hospital North, Colorado Springs, Colorado, United States
Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, 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
Beebe Health Campus, Rehoboth Beach, 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
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
Northside Hospital, Atlanta, Georgia, United States
Northside Hospital-Cherokee, Canton, Georgia, United States
Northside Hospital-Forsyth, Cumming, Georgia, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Centralia Oncology Clinic, Centralia, 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
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
OSF Saint Francis Medical Center, Peoria, 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
Goshen Center for Cancer Care, Goshen, Indiana, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic - Ames, Ames, Iowa, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Anne Arundel Medical Center, Annapolis, Maryland, 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
University of Maryland Shore Medical Center at Easton, Easton, Maryland, United States
TidalHealth Richard A Henson Cancer Institute, Ocean Pines, Maryland, United States
TidalHealth Peninsula Regional, Salisbury, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Saint Joseph Mercy Brighton, Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States
Saint Joseph Mercy Canton, Canton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States
Caro Cancer Center, Caro, 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 Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette, Marlette, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, United States
Ascension Saint Joseph Hospital, Tawas City, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch, West Branch, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington, Farmington, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Sands Cancer Center, Canandaigua, New York, United States
Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States
Northern Westchester Hospital, Mount Kisco, New York, United States
Wilmot Cancer Institute Radiation Oncology at Greece, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Wilmot Cancer Institute at Webster, Webster, 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
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
Mercy Health Perrysburg Cancer Center, Perrysburg, Ohio, United States
Mercy Health - Saint Anne Hospital, Toledo, Ohio, United States
University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Saint Luke's Cancer Center - Allentown, Allentown, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
Chambersburg Hospital, Chambersburg, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Saint Luke's Hospital-Anderson Campus, Easton, Pennsylvania, United States
Ephrata Cancer Center, Ephrata, Pennsylvania, United States
Saint Vincent Hospital, Erie, Pennsylvania, United States
Adams Cancer Center, Gettysburg, Pennsylvania, United States
Sechler Family Cancer Center, Lebanon, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Jefferson Torresdale Hospital, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Saint Luke's Hospital - Upper Bucks Campus, Quakertown, Pennsylvania, United States
Saint Luke's Hospital-Quakertown Campus, Quakertown, Pennsylvania, United States
Saint Luke's Hospital - Monroe Campus, Stroudsburg, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
WellSpan Health-York Cancer Center, York, Pennsylvania, United States
WellSpan Health-York Hospital, York, Pennsylvania, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Gibbs Cancer Center-Gaffney, Gaffney, South Carolina, United States
Self Regional Healthcare, Greenwood, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union, Union, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, 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
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Drexel Town Square Health Center, Oak Creek, Wisconsin, United States
Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend, Wisconsin, United States
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Name: Vinai Gondi
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR