Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

Who is this study for? Patients with a gross totally resected grade II meningioma
What treatments are being studied? Radiation Therapy
Status: Recruiting
Location: See all (190) locations...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• PRIOR TO STEP 1 REGISTRATION:

• The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution; WHO grade will be assigned according to WHO 2016 criteria

• Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor; GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings

• Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection

• For step 1 registration the operating neurosurgeon must provide the modified Simpson grade

• GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

• If the patient is a primary English speaker, the patient must participate in the NCF and patient reported outcomes part of the study; if the patient is a primary French or Spanish speaker, the patient must participate in the patient reported outcomes part of the study

• NOTE: Central pathology review must occur between steps 1 and 2 of registration; once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization

• PRIOR TO STEP 2 REGISTRATION:

• Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration

• History/physical examination, including neurologic examination within 60 days prior to step 2 registration

• Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration

• If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Active, not recruiting
Birmingham
Arizona
Mayo Clinic Hospital in Arizona
Active, not recruiting
Phoenix
Saint Joseph's Hospital and Medical Center
Suspended
Phoenix
Mayo Clinic in Arizona
Active, not recruiting
Scottsdale
Banner University Medical Center - Tucson
Recruiting
Tucson
University of Arizona Cancer Center-North Campus
Recruiting
Tucson
University of Arizona Cancer Center-Orange Grove Campus
Recruiting
Tucson
California
Kaiser Permanente-Anaheim
Recruiting
Anaheim
Sutter Cancer Centers Radiation Oncology Services-Auburn
Recruiting
Auburn
Kaiser Permanente Dublin
Recruiting
Dublin
Kaiser Permanente Los Angeles Medical Center
Recruiting
Los Angeles
Los Angeles County-USC Medical Center
Recruiting
Los Angeles
USC / Norris Comprehensive Cancer Center
Recruiting
Los Angeles
Memorial Medical Center
Recruiting
Modesto
Kaiser Permanente Oakland-Broadway
Recruiting
Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center
Recruiting
Orange
Stanford Cancer Institute Palo Alto
Active, not recruiting
Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center
Recruiting
Rancho Cordova
Rohnert Park Cancer Center
Recruiting
Rohnert Park
Sutter Cancer Centers Radiation Oncology Services-Roseville
Recruiting
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Recruiting
Roseville
South Sacramento Cancer Center
Recruiting
Sacramento
Sutter Medical Center Sacramento
Recruiting
Sacramento
Kaiser Permanente Medical Center - Santa Clara
Recruiting
Santa Clara
Kaiser Permanente Cancer Treatment Center
Recruiting
South San Francisco
Sutter Solano Medical Center/Cancer Center
Recruiting
Vallejo
Connecticut
Hartford Hospital
Recruiting
Hartford
Yale University
Recruiting
New Haven
Delaware
Christiana Care Health System-Christiana Hospital
Active, not recruiting
Newark
Helen F Graham Cancer Center
Active, not recruiting
Newark
Beebe Health Campus
Active, not recruiting
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center
Active, not recruiting
Seaford
Florida
Boca Raton Regional Hospital
Active, not recruiting
Boca Raton
UM Sylvester Comprehensive Cancer Center at Coral Gables
Recruiting
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Recruiting
Deerfield Beach
Baptist MD Anderson Cancer Center
Recruiting
Jacksonville
Miami Cancer Institute
Active, not recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
AdventHealth East Orlando
Suspended
Orlando
AdventHealth Orlando
Recruiting
Orlando
Moffitt Cancer Center
Recruiting
Tampa
Georgia
Emory Proton Therapy Center
Recruiting
Atlanta
Emory Saint Joseph's Hospital
Recruiting
Atlanta
Emory University Hospital/Winship Cancer Institute
Recruiting
Atlanta
Grady Health System
Recruiting
Atlanta
Northside Hospital
Active, not recruiting
Atlanta
Piedmont Hospital
Recruiting
Atlanta
Northside Hospital-Forsyth
Active, not recruiting
Cumming
Piedmont Fayette Hospital
Recruiting
Fayetteville
Piedmont Newnan Hospital
Recruiting
Newnan
Piedmont Henry Hospital
Recruiting
Stockbridge
Hawaii
Queen's Medical Center
Recruiting
Honolulu
The Cancer Center of Hawaii-Liliha
Recruiting
Honolulu
Iowa
Iowa Methodist Medical Center
Active, not recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Active, not recruiting
Iowa City
Illinois
Northwestern University
Recruiting
Chicago
Rush University Medical Center
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Decatur Memorial Hospital
Active, not recruiting
Decatur
NorthShore University HealthSystem-Evanston Hospital
Recruiting
Evanston
Northwestern Medicine Cancer Center Delnor
Recruiting
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Recruiting
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Recruiting
Highland Park
Loyola University Medical Center
Recruiting
Maywood
Northwestern Medicine Cancer Center Warrenville
Recruiting
Warrenville
Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Active, not recruiting
Indianapolis
IU Health Methodist Hospital
Active, not recruiting
Indianapolis
Kansas
University of Kansas Cancer Center
Recruiting
Kansas City
University of Kansas Cancer Center-Overland Park
Recruiting
Overland Park
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Louisiana
LSU Health Sciences Center at Shreveport
Recruiting
Shreveport
Massachusetts
Tufts Medical Center
Recruiting
Boston
Maryland
Maryland Proton Treatment Center
Active, not recruiting
Baltimore
University of Maryland/Greenebaum Cancer Center
Active, not recruiting
Baltimore
Maine
MaineHealth Coastal Cancer Treatment Center
Recruiting
Bath
Maine Medical Center-Bramhall Campus
Recruiting
Portland
MaineHealth Cancer Care Center of York County
Recruiting
Sanford
Maine Medical Center- Scarborough Campus
Recruiting
Scarborough
Michigan
Saint Joseph Mercy Hospital
Suspended
Ann Arbor
University of Michigan Comprehensive Cancer Center
Active, not recruiting
Ann Arbor
Saint Joseph Mercy Chelsea
Suspended
Chelsea
Henry Ford Macomb Hospital-Clinton Township
Recruiting
Clinton Township
Ascension Saint John Hospital
Suspended
Detroit
Henry Ford Hospital
Recruiting
Detroit
Trinity Health Saint Mary Mercy Livonia Hospital
Suspended
Livonia
Ascension Saint Mary's Hospital
Recruiting
Saginaw
Saint John Macomb-Oakland Hospital
Suspended
Warren
Henry Ford West Bloomfield Hospital
Recruiting
West Bloomfield
Minnesota
Essentia Health Cancer Center
Recruiting
Duluth
Miller-Dwan Hospital
Recruiting
Duluth
Mayo Clinic in Rochester
Recruiting
Rochester
Park Nicollet Clinic - Saint Louis Park
Recruiting
Saint Louis Park
Regions Hospital
Recruiting
Saint Paul
Missouri
University of Missouri - Ellis Fischel
Suspended
Columbia
Siteman Cancer Center at West County Hospital
Recruiting
Creve Coeur
Siteman Cancer Center-South County
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Recruiting
Saint Peters
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
Montana
Benefis Healthcare- Sletten Cancer Institute
Recruiting
Great Falls
Kalispell Regional Medical Center
Recruiting
Kalispell
North Carolina
UNC Lineberger Comprehensive Cancer Center
Active, not recruiting
Chapel Hill
Nebraska
University of Nebraska Medical Center
Active, not recruiting
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
Active, not recruiting
Basking Ridge
Memorial Sloan Kettering Monmouth
Active, not recruiting
Middletown
Memorial Sloan Kettering Bergen
Active, not recruiting
Montvale
Rutgers Cancer Institute of New Jersey
Suspended
New Brunswick
Rutgers New Jersey Medical School
Recruiting
Newark
Capital Health Medical Center-Hopewell
Recruiting
Pennington
ProCure Proton Therapy Center-Somerset
Active, not recruiting
Somerset
Robert Wood Johnson University Hospital Somerset
Active, not recruiting
Somerville
New Mexico
University of New Mexico Cancer Center
Recruiting
Albuquerque
New York
New York-Presbyterian/Brooklyn Methodist Hospital
Recruiting
Brooklyn
Memorial Sloan Kettering Commack
Active, not recruiting
Commack
The New York Hospital Medical Center of Queens
Active, not recruiting
Flushing
Memorial Sloan Kettering Westchester
Active, not recruiting
Harrison
Memorial Sloan Kettering Cancer Center
Active, not recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Active, not recruiting
New York
NYP/Weill Cornell Medical Center
Recruiting
New York
University of Rochester
Active, not recruiting
Rochester
Memorial Sloan Kettering Nassau
Active, not recruiting
Uniondale
Ohio
Case Western Reserve University
Recruiting
Cleveland
Cleveland Clinic Foundation
Recruiting
Cleveland
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Mercy Cancer Center-Elyria
Suspended
Elyria
UH Seidman Cancer Center at Lake Health Mentor Campus
Recruiting
Mentor
ProMedica Flower Hospital
Recruiting
Sylvania
UHHS-Westlake Medical Center
Recruiting
Westlake
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Mount Hood Medical Center
Recruiting
Gresham
Legacy Good Samaritan Hospital and Medical Center
Recruiting
Portland
Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus
Active, not recruiting
Bethlehem
Christiana Care Health System-Concord Health Center
Active, not recruiting
Chadds Ford
Geisinger Medical Center
Recruiting
Danville
Geisinger Medical Oncology-Lewisburg
Recruiting
Lewisburg
Lewistown Hospital
Recruiting
Lewistown
Fox Chase Cancer Center
Active, not recruiting
Philadelphia
Temple University Hospital
Recruiting
Philadelphia
Thomas Jefferson University Hospital
Active, not recruiting
Philadelphia
Geisinger Cancer Services-Pottsville
Recruiting
Pottsville
Geisinger Wyoming Valley/Henry Cancer Center
Recruiting
Wilkes-barre
Lankenau Medical Center
Recruiting
Wynnewood
South Carolina
Prisma Health Cancer Institute - Spartanburg
Suspended
Boiling Springs
Medical University of South Carolina
Active, not recruiting
Charleston
Prisma Health Cancer Institute - Eastside
Suspended
Greenville
Prisma Health Cancer Institute - Faris
Suspended
Greenville
Prisma Health Cancer Institute - Greer
Suspended
Greer
Prisma Health Cancer Institute - Seneca
Suspended
Seneca
Tennessee
Vanderbilt University/Ingram Cancer Center
Active, not recruiting
Nashville
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
M D Anderson Cancer Center
Recruiting
Houston
University of Texas Health Science Center at San Antonio
Active, not recruiting
San Antonio
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
Recruiting
American Fork
Logan Regional Hospital
Recruiting
Logan
Intermountain Medical Center
Recruiting
Murray
McKay-Dee Hospital Center
Recruiting
Ogden
Utah Valley Regional Medical Center
Recruiting
Provo
Riverton Hospital
Recruiting
Riverton
LDS Hospital
Recruiting
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
Active, not recruiting
Richmond
Vermont
Norris Cotton Cancer Center-North
Recruiting
Saint Johnsbury
Washington
University of Washington Medical Center - Montlake
Recruiting
Seattle
Legacy Salmon Creek Hospital
Recruiting
Vancouver
Wisconsin
Marshfield Medical Center-EC Cancer Center
Recruiting
Eau Claire
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Froedtert Menomonee Falls Hospital
Recruiting
Menomonee Falls
Medical College of Wisconsin
Recruiting
Milwaukee
Marshfield Clinic-Minocqua Center
Recruiting
Minocqua
Marshfield Medical Center-Rice Lake
Recruiting
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Recruiting
Stevens Point
Diagnostic and Treatment Center
Recruiting
Weston
Other Locations
Canada
Tom Baker Cancer Centre
Suspended
Calgary
Cross Cancer Institute
Recruiting
Edmonton
Juravinski Cancer Centre at Hamilton Health Sciences
Suspended
Hamilton
London Regional Cancer Program
Suspended
London
CHUM - Centre Hospitalier de l'Universite de Montreal
Recruiting
Montreal
The Research Institute of the McGill University Health Centre (MUHC)
Recruiting
Montreal
Allan Blair Cancer Centre
Active, not recruiting
Regina
University Health Network-Princess Margaret Hospital
Recruiting
Toronto
India
Tata Memorial Hospital
Recruiting
Mumbai
Japan
Hiroshima University Hospital
Suspended
Hiroshima City
Kyorin University Hospital
Recruiting
Mitaka-shi
Saitama Medical University International Medical Center
Suspended
Saitama
Hokkaido University Hospital
Recruiting
Sapporo
Keio University
Suspended
Shinjuku-ku
Iwate Medical University Hospital
Recruiting
Shiwa-gun
National Cancer Center Hospital
Recruiting
Tokyo
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
Recruiting
Riyadh
Contact Information
Primary
C. Leland Rogers, MD
leland.rogers@dignityhealth.org
602-406-6761
Time Frame
Start Date: June 14, 2017
Estimated Completion Date: August 31, 2027
Participants
Target number of participants: 148
Treatments
Other: Arm I (Clinical Observation)
Patients undergo observation after gross total resection.
Experimental: Arm II (Radiation Therapy)
Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions after gross total resection.
Authors
Mark C. Smith, Nicholas A. Blondin, Derek S. Tsang, John E. Mignano, Kathleen C. Toomey, Vinai Gondi, Mitchell Machtay, Gary V. Burton, Heath B. Mackley, Adam W. Nowlan, Robert J. Behrens, Xiao-Tang Kong, Na Tosha N. Gatson, Bryan A. Faller, Richard A. Peterson, Anupama Chundury, Charles E. Rutter, Eric L. Chang, Yuhchyau Chen, Andrew Y. Kee, Navid Redjal, Tamer R. Abdelrhman, Lola Chambless, Anand Mahadevan, Scott G. Soltys, Ryan T. Merrell, Steven P. Howard, Chi Zhang, Richard L. Crownover, Ken Tatebe, Minesh P. Mehta, Matthew Koshy, Bruce E. Brockstein, Christopher U. Jones, Herbert B. Newton, Jonathan P. Knisely, Jiayi Huang, John M. Schallenkamp, Benjamin E. Lawler, Albert S. DeNittis, Grant K. Hunter, Gregory A. Masters, Gregg H. Goldin, Lia M. Halasz, Abhijit B. Saste, Sean Sachdev, Colette Shen, Matthew D. Cheney, Carlos A. Alemany, Kenneth W. Merrell, Joseph A. Bovi, Eleanor M. Walker, Joseph P. Weiner, Joshua Lukenbill, Michael D. Zurenko, Eric A. Mellon, Tolga Tuncer, Puja Nistala, Edward Melian, Mark D. Anderson, Wenyin Shi, Samir Narayan, Nicholas DiBella, David L. Grisell, Benny J. Liem, Hani L. Ashamalla, Steven J. Rubin, Rupa G. Juthani, Ahmad Daher, Barbara J. Fisher, Joshua D. Palmer, Yan Ji, Bree R. Eaton, Samantha A. Seaward, Nimisha Deb, Scott M. Lindhorst, Debra N. Yeboa, Alan C. Hartford, Fen Wang, Serah Choi, Michael R. Girvigian, James L. Wade, Benjamin T. Marchello, Terence S. Herman, Michelle M. Kim, Bret E. Friday, Mark V. Mishra, James M. Chimenti, John B. Fiveash, Christina I. Tsien, Edmund L. Simon, Curtis T. Miyamoto, John L. Villano, Martin K. Nicholas, Gordon A. Watson, Michael R. Olson, C. Leland Rogers, J. S. Thompson, Tony J. Wang, Timothy J. Harris, Ameen Al-Omair, Richard Y. Lee, Gerald W. Lim, Samir I. Patel, Takaaki Beppu, Baldassarre Stea, Masahiro Toda, Zabi Wardak, Fumiyuki Yamasaki, Motoo Nagane, John H. Suh, Kaoru Kurisu, Shigeru Yamaguchi, T. Jonathan Yang, Hsiang-Hsuan M. Yu, Stacy D. D'Andre, Yoshitaka Narita, Jean-Paul Bahary, Tejpal Gupta, Jeffrey N. Greenspoon, Michelle J. Ferguson, Bassam S. Abdulkarim, Ryo Nishikawa
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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