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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Vinai Gondi

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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