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

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  • University of New Mexico Cancer CenterAlbuquerque, Egyesült ÁllamokNo longer taking part
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  • UT Southwestern/Simmons Cancer Center-DallasDallas, Egyesült ÁllamokNo longer taking part
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  • UM Sylvester Comprehensive Cancer Center at DoralDoral, Egyesült ÁllamokNo longer taking part
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  • NorthShore University HealthSystem-Evanston HospitalEvanston, Egyesült ÁllamokNo longer taking part
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  • The New York Hospital Medical Center of QueensFlushing, Egyesült ÁllamokNo longer taking part
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  • NorthShore University HealthSystem-Glenbrook HospitalGlenview, Egyesült ÁllamokNo longer taking part
  • Trinity Health Grand Rapids HospitalGrand Rapids, Egyesült ÁllamokNo longer taking part
  • Benefis Sletten Cancer InstituteGreat Falls, Egyesült ÁllamokNo longer taking part
  • Prisma Health Cancer Institute - EastsideGreenville, Egyesült ÁllamokNo longer taking part
  • Prisma Health Cancer Institute - FarisGreenville, Egyesült ÁllamokNo longer taking part
  • Prisma Health Cancer Institute - GreerGreer, Egyesült ÁllamokNo longer taking part
  • Legacy Mount Hood Medical CenterGresham, Egyesült ÁllamokNo longer taking part
  • Memorial Sloan Kettering WestchesterHarrison, Egyesült ÁllamokNo longer taking part
  • Hartford HospitalHartford, Egyesült ÁllamokNo longer taking part
  • NorthShore University HealthSystem-Highland Park HospitalHighland Park, Egyesült ÁllamokNo longer taking part
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, Egyesült ÁllamokNo longer taking part
  • Queen's Medical CenterHonolulu, Egyesült ÁllamokNo longer taking part
  • The Cancer Center of Hawaii-LilihaHonolulu, Egyesült ÁllamokNo longer taking part
  • UT MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
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  • IU Health Methodist HospitalIndianapolis, Egyesült ÁllamokNo longer taking part
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, Egyesült ÁllamokNo longer taking part
  • University of Mississippi Medical CenterJackson, Egyesült ÁllamokNo longer taking part
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  • USC / Norris Comprehensive Cancer CenterLos Angeles, Egyesült ÁllamokNo longer taking part
  • The James Graham Brown Cancer Center at University of LouisvilleLouisville, Egyesült ÁllamokNo longer taking part
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  • University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, Egyesült ÁllamokNo longer taking part
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, Egyesült ÁllamokNo longer taking part
  • Marshfield Medical Center-MarshfieldMarshfield, Egyesült ÁllamokNo longer taking part
  • Loyola University Medical CenterMaywood, Egyesült ÁllamokNo longer taking part
  • Froedtert Menomonee Falls HospitalMenomonee Falls, Egyesült ÁllamokNo longer taking part
  • UH Seidman Cancer Center at Lake Health Mentor CampusMentor, Egyesült ÁllamokNo longer taking part
  • Miami Cancer InstituteMiami, Egyesült ÁllamokNo longer taking part
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Egyesült ÁllamokNo longer taking part
  • Memorial Sloan Kettering MonmouthMiddletown, Egyesült ÁllamokNo longer taking part
  • Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
  • Abbott-Northwestern HospitalMinneapolis, Egyesült ÁllamokNo longer taking part
  • Marshfield Medical Center - MinocquaMinocqua, Egyesült ÁllamokNo longer taking part
  • Memorial Medical CenterModesto, Egyesült ÁllamokNo longer taking part
  • Memorial Sloan Kettering BergenMontvale, Egyesült ÁllamokNo longer taking part
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  • Vanderbilt University/Ingram Cancer CenterNashville, Egyesült ÁllamokNo longer taking part
  • Jersey Shore Medical CenterNeptune City, Egyesült ÁllamokNo longer taking part
  • Rutgers Cancer Institute of New JerseyNew Brunswick, Egyesült ÁllamokNo longer taking part
  • Yale UniversityNew Haven, Egyesült ÁllamokNo longer taking part
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  • University of Oklahoma Health Sciences CenterOklahoma City, Egyesült ÁllamokNo longer taking part
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A vizsgálat adatai

Ki végzi
NRG Oncology
Azonosító
NCT03180268
A regiszteradat frissítve
2026. október 2.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: 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.

Kizáró feltételek: Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas; 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); 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; 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).

ClinicalTrials.gov NCT03180268