Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma
NCT ID: NCT00895622
Last Updated: 2023-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
244 participants
INTERVENTIONAL
2009-06-30
2023-08-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low Risk
No treatment given.
No interventions assigned to this group
Intermediate Risk
54 Gy radiotherapy
54 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.
High Risk
60 Gy radiotherapy
60 Gy radiotherapy
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.
Interventions
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54 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.
60 Gy radiotherapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 1.1 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.
* 1.2 In cases of newly diagnosed or surgically treated recurrent meningioma, the operating neurosurgeon must provide a Simpson grade for the degree of resection.
2. History/physical examination, including neurologic examination, within 8 weeks prior to Step 2 registration
3. Zubrod Performance Status 0-1
4. Age ≥ 18
5. 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.
* 5.1 Group I: All group I patients will have surgery. Preoperative and postoperative MRIs are thus required in order to assess resection extent.
* 5.2 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.
* 5.3 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.
6. For woman of childbearing potential who are intermediate or high risk:
* 6.1 Negative serum pregnancy test within 14 days prior to Step 2 registration
* 6.2 The patient must agree to practice adequate contraception from the time of the negative serum pregnancy test throughout the entire course of EBRT.
7. Patient must sign study-specific informed consent prior to study entry
Exclusion Criteria
2. Multiple meningiomas
3. Hemangiopericytoma
4. Major medical illnesses or psychiatric impairments which, in the investigators opinion, will prevent administration or completion of the protocol therapy or preclude informed consent
5. Previous radiation therapy to the scalp, cranium, brain, or skull base
6. 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)
7. Patients with severe, active comorbidity including, but not restricted to:
* 7.1 Unstable angina and/or congestive heart failure requiring hospitalization at the time of Step 2 registration
* 7.2 Transmural myocardial infarction within the last 6 months
* 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of Step 2 registration
* 7.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of Step 2 registration
* 7.5 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.
* 7.6 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.
* 7.7 Active connective tissue disorders such as lupus or scleroderma if the patient is intermediate or high risk
8. Inability to receive gadolinium
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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C. Leland Rogers, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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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
St 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
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
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, 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
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, 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
Countries
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References
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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.
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.
Other Identifiers
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CDR0000641815
Identifier Type: -
Identifier Source: secondary_id
RTOG-0539
Identifier Type: -
Identifier Source: org_study_id
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