RECRUITING

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

Talk to us

Conditions

Grade II MeningiomaIntracranial Meningioma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-06-14
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03180268

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRIOR TO STEP 1 REGISTRATION:
  2. * 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
  3. * 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
  4. * 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
  5. * For step 1 registration the operating neurosurgeon must provide the modified Simpson grade
  6. * 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
  7. * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  8. * 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
  9. * 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
  10. * PRIOR TO STEP 2 REGISTRATION:
  11. * Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
  12. * History/physical examination, including neurologic examination within 60 days prior to step 2 registration
  13. * Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
  14. * 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
  1. * Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
  2. * Definitive evidence of metastatic meningioma
  3. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)
  4. * Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas
  5. * Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent; these include, but are not restricted to:
  6. * Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
  7. * Transmural myocardial infarction within the last 6 months prior to step 2 registration
  8. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
  9. * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
  10. * Type II neurofibromatosis (NF2)
  11. * Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count \< 200 cells/microliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to step 2 registration
  12. * Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, etc) or receive gadolinium; note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
  13. * Pregnancy and/or nursing females

Contacts and Locations

Study Contact

C. Leland Rogers, MD
CONTACT
602-406-6761
leland.rogers@dignityhealth.org

Principal Investigator

C. Leland Rogers, MD
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704
United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806
United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706
United States
Kaiser Permanente Dublin
Dublin, California, 94568
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Memorial Medical Center
Modesto, California, 95355
United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
United States
Kaiser Permanente-Ontario
Ontario, California, 91761
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928
United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661
United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
United States
Sutter Medical Center Sacramento
Sacramento, California, 95816
United States
South Sacramento Cancer Center
Sacramento, California, 95823
United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Yale University
New Haven, Connecticut, 06520
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, 19973
United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
AdventHealth East Orlando
Orlando, Florida, 32822
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Emory Proton Therapy Center
Atlanta, Georgia, 30308
United States
Piedmont Hospital
Atlanta, Georgia, 30309
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Northside Hospital-Forsyth
Cumming, Georgia, 30041
United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214
United States
Piedmont Newnan Hospital
Newnan, Georgia, 30265
United States
Piedmont Henry Hospital
Stockbridge, Georgia, 30281
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
United States
Northwestern University
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois
Chicago, Illinois, 60612
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
United States
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805
United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Logan Health Medical Center
Kalispell, Montana, 59901
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Jersey Shore Medical Center
Neptune, New Jersey, 07753
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
United States
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534
United States
ProCure Proton Therapy Center-Somerset
Somerset, New Jersey, 08873
United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
NYP/Weill Cornell Medical Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
United States
Logan Regional Hospital
Logan, Utah, 84321
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
McKay-Dee Hospital Center
Ogden, Utah, 84403
United States
Utah Valley Regional Medical Center
Provo, Utah, 84604
United States
Riverton Hospital
Riverton, Utah, 84065
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • C. Leland Rogers, MD, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-06-14
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2017-06-14
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Grade II Meningioma
  • Intracranial Meningioma