Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas
2 other identifiers
interventional
244
2 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Longer than P75 for phase_2
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedResults Posted
Study results publicly available
January 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedSeptember 8, 2023
August 1, 2023
7.3 years
May 7, 2009
December 18, 2017
August 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (3)
Low Risk
NO INTERVENTIONNo treatment given.
Intermediate Risk
EXPERIMENTAL54 Gy radiotherapy
High Risk
EXPERIMENTAL60 Gy radiotherapy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- A histologically documented World Health Organization (WHO) grade I, II, or III meningioma, newly diagnosed or recurrent, and of any resection extent, confirmed by central pathology review. Patients are partitioned according to three groupings: Group I (low risk), Group II (intermediate risk), and Group III (high risk) as defined below:
- Group I (low risk): Patients with a newly diagnosed WHO grade I meningioma that has been gross totally resected (Simpson's grade I, II, or III resections, with no residual nodular enhancement on postoperative imaging) or subtotally resected (residual nodular enhancement or Simpson grade IV or V excision). The extent of resection will be based upon the neurosurgeons' assessment and postoperative MR imaging.
- Group II (intermediate risk): Patients with a newly diagnosed gross totally resected WHO grade II meningioma or patients with a recurrent WHO grade I meningioma irrespective of the resection extent. Resection extent will be recorded on the same basis described above for the low-risk group.
- Group III (high risk): Patients with a newly diagnosed or a recurrent WHO grade III meningioma of any resection extent; patients with a recurrent WHO grade II meningioma of any resection extent; or patients with a newly diagnosed subtotally resected WHO grade II meningioma. In the setting of a newly diagnosed meningioma, the histologic diagnosis must have been reached within 6 months of Step 2 registration. Resection extent will be recorded on the same basis described above for the low-risk group.
- In the setting of a newly diagnosed meningioma, the histologic diagnosis must have been reached within 24 weeks prior to Step 2 registration. In the setting of a recurrent meningioma, there are no such time constraints. Additional resection or biopsy is encouraged for patients with recurrence but is not requisite. If further biopsy or resection is performed at recurrence, these specimens must be submitted; submission of the original pathology specimens is encouraged but not required. The diagnosis of recurrence solely on the basis of imaging findings is permitted, but if no additional resection is performed, specimens from prior resection must be submitted.
- In cases of newly diagnosed or surgically treated recurrent meningioma, the operating neurosurgeon must provide a Simpson grade for the degree of resection.
- History/physical examination, including neurologic examination, within 8 weeks prior to Step 2 registration
- Zubrod Performance Status 0-1
- Age ≥ 18
- All patients must have a magnetic resonance imaging (MRI) scan within 12 weeks prior to Step 2 registration. Both preoperative and postoperative MRIs are required for all newly diagnosed patients in groups I, II, or III. In the setting of group II or III patients with recurrent/progressive meningioma and without recent surgery, a pre-operative study may not apply, although MRI documentation of recurrence or progression is required. MRIs must include precontrast T1, T2, and flair images and multiplanar (axial, sagittal, and coronal) postcontrast T1. The postoperative study must be completed within 12 weeks of surgery.
- Group I: All group I patients will have surgery. Preoperative and postoperative MRIs are thus required in order to assess resection extent.
- Group II: Surgery will be undertaken for the subgroup with a gross totally resected WHO grade II meningioma. For these patients preoperative and postoperative MRIs are necessitated. For the other subgroup with recurrent WHO grade I meningioma, preoperative and postoperative MRIs are required if surgery is undertaken for the recurrent/progressive tumor. However, only the follow-up imaging documenting recurrence or progression will apply if further surgery is not completed.
- Group III: Surgery will be undertaken for the subgroup with a newly diagnosed WHO grade III meningioma. For these patients preoperative and postoperative MRIs are obligatory. For the subgroups with recurrent WHO grade II or III meningioma, preoperative and postoperative MRIs are required if surgery is undertaken for the recurrent/progressive tumor. However, only the follow-up imaging documenting recurrence or progression will apply if further surgery is not completed.
- For woman of childbearing potential who are intermediate or high risk:
- Negative serum pregnancy test within 14 days prior to Step 2 registration
- +2 more criteria
You may not qualify if:
- Extracranial meningioma
- Multiple meningiomas
- Hemangiopericytoma
- Major medical illnesses or psychiatric impairments which, in the investigators opinion, will prevent administration or completion of the protocol therapy or preclude informed consent
- Previous radiation therapy to the scalp, cranium, brain, or skull base
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Patients with severe, active comorbidity including, but not restricted to:
- Unstable angina and/or congestive heart failure requiring hospitalization at the time of Step 2 registration
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of Step 2 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of Step 2 registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Active connective tissue disorders such as lupus or scleroderma if the patient is intermediate or high risk
- Inability to receive gadolinium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (78)
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
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
Related Publications (3)
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.
PMID: 26493095RESULTRogers 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.
PMID: 31786276DERIVEDRogers 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.
PMID: 28984517DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
C. Leland Rogers, MD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2009
First Posted
May 8, 2009
Study Start
June 1, 2009
Primary Completion
September 1, 2016
Study Completion
August 15, 2023
Last Updated
September 8, 2023
Results First Posted
January 19, 2018
Record last verified: 2023-08