Spots Global Cancer Trial Database for Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
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Trial Identification
Brief Title: Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
Official Title: Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
Study ID: NCT03180268
Study Description
Brief Summary: This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Detailed Description: PRIMARY OBJECTIVES: I. To determine, in terms of progression-free survival (PFS), the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Outcomes and patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Tissue microarray construction, and assessment of pHH3 mitotic index and molecular correlates to OS. OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection. ARM I: Patients undergo observation. ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each). After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
Kaiser Permanente-Anaheim, Anaheim, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States
Kaiser Permanente Dublin, Dublin, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Memorial Medical Center, Modesto, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
Kaiser Permanente-Ontario, Ontario, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States
Rohnert Park Cancer Center, Rohnert Park, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
South Sacramento Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Kaiser Permanente Cancer Treatment Center, South San Francisco, California, United States
Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States
Hartford Hospital, Hartford, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States
Boca Raton Regional Hospital, Boca Raton, Florida, 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
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
AdventHealth East Orlando, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Grady Health System, Atlanta, Georgia, United States
Emory Proton Therapy Center, Atlanta, Georgia, United States
Piedmont Hospital, 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-Forsyth, Cumming, Georgia, United States
Piedmont Fayette Hospital, Fayetteville, Georgia, United States
Piedmont Newnan Hospital, Newnan, Georgia, United States
Piedmont Henry Hospital, Stockbridge, Georgia, United States
Queen's Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
IU Health Methodist Hospital, Indianapolis, Indiana, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, United States
MaineHealth Coastal Cancer Treatment Center, Bath, Maine, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
MaineHealth Cancer Care Center of York County, Sanford, Maine, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
Maryland Proton Treatment Center, Baltimore, Maryland, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Essentia Health Cancer Center, Duluth, Minnesota, United States
Miller-Dwan Hospital, Duluth, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
MU Health - University Hospital/Ellis Fischel Cancer Center, Columbia, Missouri, 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 Saint Peters Hospital, Saint Peters, Missouri, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School, Newark, New Jersey, United States
Capital Health Medical Center-Hopewell, Pennington, New Jersey, United States
ProCure Proton Therapy Center-Somerset, Somerset, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
The New York Hospital Medical Center of Queens, Flushing, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Westchester Medical Center, Valhalla, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, 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
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, United States
Logan Regional Hospital, Logan, Utah, United States
Intermountain Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center, Provo, Utah, United States
Riverton Hospital, Riverton, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Legacy Salmon Creek Hospital, Vancouver, Washington, United States
Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Drexel Town Square Health Center, Oak Creek, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Tata Memorial Hospital, Mumbai, , India
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Iwate Medical University Hospital, Shiwa-gun, Iwate, Japan
Kyorin University Hospital, Mitaka-shi, Tokyo, Japan
Keio University, Shinjuku-ku, Tokyo, Japan
Hiroshima University Hospital, Hiroshima City, , Japan
Saitama Medical University International Medical Center, Saitama, , Japan
National Cancer Center Hospital, Tokyo, , Japan
King Faisal Specialist Hospital and Research Centre, Riyadh, , Saudi Arabia
Contact Details
Name: C. Leland Rogers, MD
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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