Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas
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.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 groups according to
risk.
- Group 1 (low-risk disease): Patients undergo observation.
- Group 2 (intermediate-risk disease): Patients undergo 3-dimensional conformal
radiotherapy or intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6
weeks.
- Group 3 (high-risk disease): Patients undergo IMRT once daily 5 days a week for 6
weeks.
After completion of study treatment, patients are followed up every 3-6 months for 3 years
and then annually for 10 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at 3 years
No
C. Leland Rogers, MD
Study Chair
Salt Lake Regional Medical Center
Unspecified
CDR0000641815
NCT00895622
June 2009
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
Emory Crawford Long Hospital | Atlanta, Georgia 30308 |
Henry Ford Macomb Hospital | Clinton Township, Michigan 48038 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Norton Suburban Hospital | Louisville, Kentucky 40207 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |