Spots Global Cancer Trial Database for Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
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Trial Identification
Brief Title: Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
Official Title: Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas
Study ID: NCT00895622
Conditions
Study Description
Brief Summary: RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether observation is more effective than radiation therapy in treating patients with meningioma. PURPOSE: This phase II trial is studying observation to see how well it works compared with radiation therapy in treating patients with grade I, grade II, or grade III meningioma.
Detailed Description: OBJECTIVES: Primary * To estimate the rates of progression-free survival at 3 years in patients with low-risk meningioma undergoing observation and in patients with intermediate- or high-risk meningioma undergoing radiotherapy. Secondary * To study the concordance, or lack thereof, between central and parent institution histopathologic diagnosis, grading, and subtyping. * To estimate the rates of overall survival at 3 years in these patients. * To estimate the incidence rates of acute and late adverse events ≥ grade 2 in patients with intermediate- or high-risk meningioma undergoing radiotherapy. * To evaluate MRI imaging predictors by central neuroradiology review at diagnosis, at any failure, and at 3 years. * To evaluate adherence to protocol-specific target and normal tissue radiotherapy parameters. This is a multicenter study. Patients are assigned to 1 of 3 groups according to risk. After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually for 10 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Mayo Clinic Hospital, Phoenix, Arizona, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Baptist-South Miami Regional Cancer Program, Miami, Florida, United States
Emory Crawford Long Hospital, Atlanta, Georgia, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest, Overland Park, Kansas, United States
CCOP - Kansas City, Prairie Village, Kansas, United States
Norton Suburban Hospital, Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough, Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Kansas City Cancer Centers - South, Kansas City, Missouri, United States
Kansas City Cancer Centers - North, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Billings Clinic - Downtown, Billings, Montana, United States
Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
Nebraska Medical Center, Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Highland Hospital of Rochester, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
Grant Medical Center Cancer Care, Columbus, Ohio, United States
Lake/University Ireland Cancer Center, Mentor, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
University of Texas Medical Branch, Galveston, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
Huntsman Cancer Institute at University of Utah, 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 Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Community Memorial Hospital Cancer Care Center, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
Door County Cancer Center at Door County Memorial Hospital, Sturgeon Bay, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: C. Leland Rogers, MD
Affiliation: Virginia Commonwealth University
Role: PRINCIPAL_INVESTIGATOR
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