[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"grade-2-meningioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:grade-2-meningioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100299608","phase-3-observation-or-radiation-therapy-in-treating-patients-with-newly-diagnosed-grade-ii-meningioma-that-has-been-completely-removed-by-surgery-100299608",false,"NCT03180268","Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery","Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* 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\n* 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)\n* 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\n* 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\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* 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\n* PRIOR TO STEP 2 REGISTRATION:\n* Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration\n* Age \\>= 18\n* History\u002Fphysical examination, including neurologic examination within 60 days prior to step 2 registration\n* Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration\n* 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\n\nExclusion Criteria:\n\n* Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma\n* Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)\n* 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)\n* Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas\n* Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and\u002For preclude informed consent; these include, but are not restricted to:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization at the time of step 2 registration\n  * Transmural myocardial infarction within the last 6 months prior to step 2 registration\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration\n  * Type II neurofibromatosis (NF2)\n  * 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 \\\u003C 200 cells\u002Fmicroliter); 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\u002Fmicroliter within 30 days prior to step 2 registration\n  * 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","ALL","18 Years",{"count":19,"type":20},163,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.",[26,27],"Grade 2 Meningioma","Intracranial Meningioma","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2017-09-12",{"date":36,"type":20},"2027-06-15",{"name":38,"class":39},"NRG Oncology","OTHER",215,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100368838","phase-2-lutathera-for-the-treatment-of-inoperable-progressive-meningioma-after-external-beam-radiation-therapy-100368838","NCT04082520","Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy","A Prospective, Phase II Study of Lutetium Lu 177 Dotatate (LUTATHERA®) in Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy","Inclusion Criteria:\n\n* Previous treatment for meningioma including surgery, when possible, and radiation therapy (conventional fractionated or radiosurgery). Pathologic confirmation of meningioma is not required for patients who are not surgical candidates and received radiation therapy based on magnetic resonance imaging (MRI) consistent with meningioma. Patients with prior surgery will have pathologic confirmation of meningioma with either formalin-fixed paraffin-embedded (FFPE) tumor block OR meningioma tissue slides available for submission to central pathology review\n* Radiographic evidence of meningioma progression with measurable disease, defined as an increase in size of the measurable primary lesion on imaging by 15% or more (sum of the bidirectional measurements) in an approximate 6 month time period (i.e., calculated rate of growth 15% \u002F 6 months based on available scans) or by the appearance of a new measurable lesion\n* Previous treatment with either fractionated radiation therapy or stereotactic radiosurgery at the site of progressive meningioma, without safe option for further radiotherapy\n* Willing to undergo 68Ga-DOTATATE PET imaging. 68Ga-DOTATATE PET imaging must be Krenning score must be a score of 2 or higher, suggesting somatostatin receptor expression, to be registered on the study. A PET\u002FMRI is preferred, but PET\u002FCT is permitted if a patient is not technically able to receive a PET\u002FMRI or at the discretion of the primary investigator (PI).\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm (obtained =\\\u003C 28 days prior to registration)\n* Platelet count \\>= 100,000\u002Fmm (obtained =\\\u003C 28 days prior to registration)\n* Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 28 days prior to registration)\n* Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (or total bilirubin =\\\u003C 3.0 x ULN with direct bilirubin =\\\u003C 1.5 x ULN in patients with well-documented Gilbert's syndrome) (obtained =\\\u003C 28 days prior to registration)\n* Aspartate transaminase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 28 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Fpartial thromboplastin time (PTT) =\\\u003C 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants (obtained =\\\u003C 28 days prior to registration)\n* Calculated creatinine clearance must be \\>= 40 ml\u002Fmin using the Cockcroft-Gault formula (obtained =\\\u003C 28 days prior to registration) using the Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI) equation.\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) and it is highly recommend to see study staff in Radiation Oncology, Medical Oncology and\u002For Neuro-Oncology during the Event Monitoring Phase of the study.\n* Until 21 SPECT\u002FCT slots are filled, willing to undergo SPECT\u002FCT imaging for dosimetry analysis.\n\nExclusion Criteria:\n\n* Eligibility for surgical or radiation treatment with curative intent\n* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant women (NOTE: Patients with surgical sterilization or who have been post-menopausal for at least 2 years are excluded form pregnancy testing, but this must be documented.)\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Contraindications to or intolerance of MRI\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] II, III, IV), unstable angina pectoris, uncontrolled diabetes mellitus (fasting blood glucose \\> 2 ULN), cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n\n  * Note: This includes treatment with somatostatin LAR within 4 weeks prior to enrollment, or any patient receiving treatment with short-acting octreotide that cannot be interrupted for greater than 24 hours before treatment\n* Other active malignancy =\\\u003C 2 years prior to registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of myocardial infarction =\\\u003C 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Current spontaneous urinary incontinence making impossible the safe administration of LUTATHERA\n* Untreated, refractory and\u002For symptomatic toxicity related to previous radiation therapy including radiation necrosis, radiation optic neuropathy, or radiation retinopathy\n* Optic nerve sheath meningioma, extracranial meningioma",{"count":49,"type":20},42,[51],"PHASE2","This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment. WHO Grade I and Cohort WHO II\u002FIII cohorts will be evaluated.",[54,26,55,56,57],"Grade 1 Meningioma","Grade 3 Meningioma","Recurrent Meningioma","Unresectable Meningioma","2026-04-17",{"date":60,"type":32},"2026-04-22",{"date":62,"type":32},"2020-04-14",{"date":64,"type":20},"2032-03-04",{"name":66,"class":39},"Mayo Clinic",1]