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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibility)
* Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. 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
* GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, 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. 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
* 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 10 business 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
* Age \>= 18
* 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

Exclusion Criteria:

* Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma
* Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)
* 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)
* Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas
* 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:

  * Unstable angina and/or congestive heart failure requiring hospitalization at the time of step 2 registration
  * Transmural myocardial infarction within the last 6 months prior to step 2 registration
  * 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
  * Type II neurofibromatosis (NF2)
  * 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
  * Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction). 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

About the study

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.

What is being tested

Sponsor: NRG Oncology · Participants: 163 · Started: Sep 12, 2017

Contact the study team

Official record on ClinicalTrials.gov — NCT03180268

Locations in the U.S.

CaliforniaKaiser Permanente-Anaheim, Anaheim
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn
Kaiser Permanente-Bellflower, Bellflower
Kaiser Permanente Dublin, Dublin
Kaiser Permanente Los Angeles Medical Center, Los Angeles
Memorial Medical Center, Modesto
Kaiser Permanente Oakland-Broadway, Oakland
Kaiser Permanente-Ontario, Ontario
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova
Rohnert Park Cancer Center, Rohnert Park
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville
The Permanente Medical Group-Roseville Radiation Oncology, Roseville
South Sacramento Cancer Center, Sacramento
Sutter Medical Center Sacramento, Sacramento
California Pacific Medical Center-Pacific Campus, San Francisco
Kaiser Permanente Medical Center - Santa Clara, Santa Clara
Kaiser Permanente Cancer Treatment Center, South San Francisco
Sutter Solano Medical Center/Cancer Center, Vallejo
ConnecticutHartford Hospital, Hartford
Smilow Cancer Hospital Care Center-Trumbull, Trumbull
FloridaUM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral, Doral
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
Memorial Hospital West, Pembroke Pines
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation
GeorgiaEmory Proton Therapy Center, Atlanta
Emory Saint Joseph's Hospital, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
Grady Health System, Atlanta
Piedmont Hospital, Atlanta
Piedmont Fayette Hospital, Fayetteville
Piedmont Newnan Hospital, Newnan
Piedmont Henry Hospital, Stockbridge
HawaiiQueen's Medical Center, Honolulu
IllinoisNorthwestern University, Chicago
Rush MD Anderson Cancer Center, Chicago
University of Illinois, Chicago
NorthShore University HealthSystem-Evanston Hospital, Evanston
Northwestern Medicine Cancer Center Delnor, Geneva
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
Loyola University Medical Center, Maywood
Northwestern Medicine Cancer Center Warrenville, Warrenville
IowaIowa Methodist Medical Center, Des Moines
KentuckyThe James Graham Brown Cancer Center at University of Louisville, Louisville
UofL Health Medical Center Northeast, Louisville
MaineMaineHealth Coastal Cancer Treatment Center, Bath
MaineHealth Maine Medical Center - Portland, Portland
MaineHealth Cancer Care Center of York County, Sanford
MaineHealth Maine Medical Center- Scarborough, Scarborough
MassachusettsTufts Medical Center, Boston
MichiganHenry Ford Macomb Hospital-Clinton Township, Clinton Township
Henry Ford Hospital, Detroit
Trinity Health Grand Rapids Hospital, Grand Rapids
Henry Ford West Bloomfield Hospital, West Bloomfield
University of Michigan Health - West, Wyoming
MinnesotaEssentia Health Cancer Center, Duluth
Miller-Dwan Hospital, Duluth
Abbott-Northwestern Hospital, Minneapolis
Mayo Clinic in Rochester, Rochester
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
MissouriSiteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
MontanaBenefis Sletten Cancer Institute, Great Falls
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyEnglewood Hospital and Medical Center, Englewood
Jersey Shore Medical Center, Neptune City
Rutgers Cancer Institute of New Jersey, New Brunswick
Capital Health Medical Center-Hopewell, Pennington
New MexicoUniversity of New Mexico Cancer Center, Albuquerque
New YorkNew York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn
OhioCase Western Reserve University, Cleveland
Cleveland Clinic Foundation, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor
ProMedica Flower Hospital, Sylvania
PennsylvaniaGeisinger Medical Center, Danville
Geisinger Medical Oncology-Lewisburg, Lewisburg
Lewistown Hospital, Lewistown
Geisinger Cancer Services-Pottsville, Pottsville
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
TexasUT Southwestern/Simmons Cancer Center-Dallas, Dallas
UtahAmerican Fork Hospital / Huntsman Intermountain Cancer Center, American Fork
Logan Regional Hospital, Logan
Intermountain Medical Center, Murray
McKay-Dee Hospital Center, Ogden
Utah Valley Regional Medical Center, Provo
Riverton Hospital, Riverton
LDS Hospital, Salt Lake City
VermontDartmouth Cancer Center - North, Saint Johnsbury
WisconsinLanglade Hospital and Cancer Center, Antigo
Marshfield Medical Center-EC Cancer Center, Eau Claire
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Marshfield Medical Center-Marshfield, Marshfield
Froedtert Menomonee Falls Hospital, Menomonee Falls
Medical College of Wisconsin, Milwaukee
Marshfield Medical Center - Minocqua, Minocqua
Drexel Town Square Health Center, Oak Creek
Marshfield Medical Center-Rice Lake, Rice Lake
Aspirus Cancer Care - Stevens Point, Stevens Point
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
UW Cancer Center at ProHealth Care, Waukesha
Aspirus Regional Cancer Center, Wausau
Marshfield Medical Center - Weston, Weston
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.