Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas
Sponsor study identifier
Secondary identifiers
interventional
244
2 countries
78
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
August 15, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2009
Actual (reported)May 8, 2009
Actual (reported)June 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2016
Actual (reported)January 19, 2018
Actual (reported)August 15, 2023
Actual (reported)Progression-free Survival Rate at 3 Years
Progression was determined by central review of magnetic resonance imaging (MRI) exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival (PFS) rates are estimated using the binomial method.
From registration to 3 years
Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]
From start of radiation to 90 days.
Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]
Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years.
Overall Survival Rate at 3 Years
From registration to 3 years
Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)
From registration to 3 years
Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years
Baseline, at time of first progression, and at 3 years
No treatment given.
54 Gy radiotherapy
60 Gy radiotherapy
External beam radiation therapy (EBRT) to a total dose of 54 Gy (RBE) in 30 fractions. 1.8 Gy (RBE) daily, 5 fractions per week, excluding weekends. 3D-CRT or IMRT or Proton allowed.
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
University of Florida Shands Cancer Center
Rogers CL, Perry A, Pugh S, Vogelbaum MA, Brachman D, McMillan W, Jenrette J, Barani I, Shrieve D, Sloan A, Bovi J, Kwok Y, Burri SH, Chao ST, Spalding AC, Anscher MS, Bloom B, Mehta M. Pathology concordance levels for meningioma classification and grading in NRG Oncology RTOG Trial 0539. Neuro Oncol. 2016 Apr;18(4):565-74. doi: 10.1093/neuonc/nov247. Epub 2015 Oct 22.
Yefet LS, Landry AP, Rogers CL, Wang JZ, Liu J, Patil V, Gui C, Ajisebutu A, Ellenbogen Y, Wei Q, Singh O, Mansouri S, Szot C, Jordan RC, Barani IJ, Straza MW, Shu HG, Pointer KB, Hunter G, Panet-Raymond V, Shi W, Perlow HK, Kavanagh BD, Gunter T, Robinson C, Pugh SL, Dicker AP, Mehta MP, Chakravarti A, Nassiri F, Aldape K, Zadeh G. Modern molecular profiling recontextualizes the NRG/RTOG 0539 trial and reveals hidden high-risk and radiotherapy-resistant meningiomas. Neuro Oncol. 2026 Jul 1;28(7):1727-1740. doi: 10.1093/neuonc/noag081.
C. Leland Rogers, MD
Virginia Commonwealth University
244 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2009
First Posted
May 8, 2009
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
External beam radiation therapy using intensity-modulated radiation therapy (IMRT) to a total dose of 60 Gy in 30 fractions. 2.0 Gy daily, 5 fractions per week, excluding weekends.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Gainesville, Florida, 32610-0232, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46202, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, 66210, United States
CCOP - Kansas City
Prairie Village, Kansas, 66208, United States
Norton Suburban Hospital
Louisville, Kentucky, 40207, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, 04074, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, 01107, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, 64131, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, 64154, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Highland Hospital of Rochester
Rochester, New York, 14620, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, 44060, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, United States
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, 54235-1495, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1Y 4E9, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6, Canada
Rogers CL, Won M, Vogelbaum MA, Perry A, Ashby LS, Modi JM, Alleman AM, Galvin J, Fogh SE, Youssef E, Deb N, Kwok Y, Robinson CG, Shu HK, Fisher BJ, Panet-Raymond V, McMillan WG, de Groot JF, Zhang P, Mehta MP. High-risk Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):790-799. doi: 10.1016/j.ijrobp.2019.11.028. Epub 2019 Nov 29.
Rogers L, Zhang P, Vogelbaum MA, Perry A, Ashby LS, Modi JM, Alleman AM, Galvin J, Brachman D, Jenrette JM, De Groot J, Bovi JA, Werner-Wasik M, Knisely JPS, Mehta MP. Intermediate-risk meningioma: initial outcomes from NRG Oncology RTOG 0539. J Neurosurg. 2018 Jul;129(1):35-47. doi: 10.3171/2016.11.JNS161170. Epub 2017 Oct 6.
Primary Completion
September 2016
Actual (reported)Study Completion
August 15, 2023
Actual (reported)Last Updated
September 8, 2023
Results First Posted
January 19, 2018
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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