[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioma-of-brain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioma-of-brain":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,81,105,131,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121",false,"NCT03213002","Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM","Phase I\u002FII Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)","CAPTEM","Inclusion Criteria:\n\n1. Be capable of giving informed consent.\n2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV\n3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide\n4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential\n5. Have a life expectancy \\> 3 months\n6. Be between the ages of 18 to 74\n7. Have a performance status KPS 70 or greater\n8. Be able to swallow pills and capsules\n9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings\n10. Have adequate bone marrow function, liver function and renal function before commencing therapy\n\nExclusion Criteria:\n\n1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.\n2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.\n3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),\n4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)\n5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).\n6. Performance status, KPS \\\u003C 70\n7. Inability to swallow pills and capsules\n8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy\n9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine\n10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance\n11. Patients with renal insufficiency or hepatic insufficiency\n12. Patients with coagulopathies\n13. Women who are pregnant or lactating.","ALL","18 Years","74 Years",{"count":21,"type":22},67,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).\n\nCapecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg\u002Fm2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.",[29,30,31,32,33,34,35,36,37],"Glioblastoma Multiforme (GBM)","Glioblastoma","Glioma of Brain","Glioblastoma, Adult","Brain Tumor","Brain Tumor, Primary","Brain Tumor Adult","Cancer","Brain Cancer","RECRUITING","2026-05-28",{"date":41,"type":42},"2026-06-01","ACTUAL",{"date":44,"type":42},"2017-06-13",{"date":46,"type":22},"2029-06",{"name":48,"class":49},"Northwell Health","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":50},"100635013","patient-voice-in-the-treatment-of-low-grade-gliomas-use-of-patient-reported-outcomes-vorasidenib-and-radiotherapy-compared-100635013","NCT07547163","Patient Voice in the Treatment of Low-grade Gliomas: Use of Patient-reported Outcomes, Vorasidenib and Radiotherapy Compared","LGG PRO's","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of IDH mutant, grade 2 glioma\n* Consent to treatment\n* Consent to the administration of PROM questionnaires\n\nExclusion Criteria:\n\n* Cognitive impairment or mental disability.\n* Dementia or severe cognitive disorders: participants who are unable to understand the questionnaire items are excluded, as the data may not be reliable.\n* Uncontrolled severe psychiatric disorders: conditions such as schizophrenia or untreated psychosis may compromise the patient's ability to provide consistent responses.\n* Language barriers.\n* Inability to understand the language of the questionnaire: participants who do not speak or understand the language in which the questionnaire is written are excluded if validated translations are not available.\n* Literacy issues: participants who are unable to read or write are excluded.\n* Non-adherence or poor cooperation.\n* Refusal to complete the questionnaires: even if the patient agrees to participate in the study, the specific refusal to complete the questionnaires leads to exclusion.\n* Conditions that may influence questionnaire outcomes.\n* Use of medications that impair cognitive abilities: the use of sedatives or antipsychotics may affect the ability to provide coherent responses, compromising the validity of PROs.",{"count":59,"type":22},90,"OBSERVATIONAL","The study aims to assess the direct patient-reported perception (PROs) of individuals affected by IDH-mutant, grade 2 gliomas undergoing radiotherapy or pharmacological treatment with vorasidenib.\n\nTo evaluate quality of life, perception of treatment-related symptoms, and anxiety levels during therapy by comparing patients receiving radiotherapy with those receiving pharmacological treatment with vorasidenib. The control group will consist of patients with IDH-mutant, grade 2 gliomas who are under clinical and radiological follow-up only.\n\nTo assess the feasibility of using PROMs in routine clinical practice. To analyze patient-reported critical issues in order to qualitatively improve care pathways.",[63,31,64,65,66],"Glioma","Low Grade Glioma of Brain","Low Grade Gliomas","IDH Mutation",[68,69,65,70,71],"Patient Reported Outcomes","glioma","grade 2 glioma","IDH mutant","2026-04-17",{"date":74,"type":42},"2026-04-23",{"date":76,"type":42},"2025-04-23",{"date":78,"type":22},"2027-10",{"name":80,"class":49},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":50},"100341675","phase-2-a-study-utilizing-escitalopram-in-glioma-patients-100341675","NCT03728673","A Study Utilizing Escitalopram in Glioma Patients","A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients","Inclusion Criteria:\n\n* Pathologically proven diagnosis of Grade IV glioma\n* Newly diagnosed disease to receive chemotherapy and\u002For radiation\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 or equivalent\n* 19 years of age or older\n* Life expectancy greater than 6 months\n* Able to provide written informed consent for study participation\n* Negative urine pregnancy test at enrollment for females of childbearing potential\n* Female participants must be either post-menopausal (free from menses for 2 or more years), surgically sterilized, or willing to use two adequate barrier forms of contraception\n\nExclusion Criteria:\n\n* Hemifield defects (obscures visual field necessary to participate in all tests)\n* Inability to undergo MRI\n* Severe renal impairment defined as Glomerular Filtration Rate (GFR) \\\u003C30 mL\u002Fminute\n* Screen positive for depression or anxiety\n* Already taking an anti-depressant (SSRI or NSRI)\n* Have problems tolerating past treatment with SSRI or NSRIs","19 Years",{"count":90,"type":22},20,[26],"Glioma is a cancer of glial cells, a class of tissue supporting neuronal function in the brain. As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also from therapy such as cranial radiation and chemotherapy, which degrades neuronal function. There is evidence that serotonin selective reuptake inhibitors (SSRIs), such as escitalopram, improve cognition or prevent cognitive decline and may also improve outcomes critical to overall survival including functional independence, psychosocial stability, and quality of life. This pilot study will evaluate the effectiveness of the selective serotonin reuptake inhibitor (SSRI) escitalopram for treating cognitive impairment in newly diagnosed grade IV glioma over a 17 week treatment period.",[31,63],[95,96,97],"serotonin selective reuptake inhibitor","cognition","escitalopram","2026-04-13",{"date":72,"type":42},{"date":101,"type":42},"2019-03-06",{"date":46,"type":22},{"name":104,"class":49},"University of Nebraska",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":60,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":50},"100350947","longitudinal-analysis-of-the-health-related-quality-of-life-in-glioma-patients-100350947","NCT03849430","Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients","Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients and Setting Up a Large-scale, Prospective Database for Glioma Patients Treated in UZ Leuven","Glioma2015","Inclusion criteria:\n\n* age ≥ 18 years\n* patients diagnosed and treated for a high- or low grade glioma\n* treatment in UZ Leuven",{"count":114,"type":22},750,"10 Years","Gliomas are the most common primary intracranial tumors, representing at least 75% of all primary malignant brain tumors. Histopathologically, gliomas are classified into different subgroups including astrocytomas (60-70%), oligodendrogliomas (10-30%), ependymomas (\\\u003C10%) and mixed gliomas (i.e. oligoastrocytomas) depending on the cell type from which they originate. The World Health Organization currently classifies gliomas based on histopathological analysis in which the presence (or absence) and the degree of specific histopathological features determines the grade of malignancy. Grade I (pilocytic astrocytoma) and grade II (diffuse astrocytoma, oligodendroglioma, mixed oligoastrocytoma, and pleomorphic xanthoastrocytoma) are termed low-grade gliomas (LGGs), whereas grade III (anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma) and grade IV (glioblastoma) represent high-grade gliomas (HGGs).\n\nGiven the incurable nature of gliomas, the maintenance or improvement of the patient's quality of life are extremely important. The benefits of multimodal treatment strategies, in terms of prolonged survival or delay of progression, have to be carefully balanced against the side effects of the treatment, which may adversely influence patient's functioning and well-being during his\u002Fher remaining life span.\n\nMeasuring a brain tumor patients functioning and well-being goes far beyond assessing (progression-free) survival or tumor response to treatment on imaging. A more integrated way to measure patients functioning and well-being is the assessment of a patient's health-related quality of life (HRQOL). HRQOL is defined as a personal self-assessed ability to function in the physical, psychological, emotional, and social domains of day-to-day life.\n\nThe main goal of this study is to perform a large-scale, prospective and long-term analysis of the HRQOL in patients diagnosed with glioma.",[31],[119,120,121],"Low grade glioma","High grade glioma","HRQOL","2025-03-26",{"date":124,"type":42},"2025-04-01",{"date":126,"type":42},"2015-12-14",{"date":128,"type":22},"2030-01-01",{"name":130,"class":49},"Universitaire Ziekenhuizen KU Leuven",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":50},"100344340","early-phase-1-azoles-targeting-recurrent-high-grade-gliomas-100344340","NCT03763396","Azoles Targeting Recurrent High Grade Gliomas","A Phase 0 Clinical Trial of Two Candidate Azoles (Ketoconazole and Posaconazole) for Patients With Recurrent High Grade Glioma","Inclusion Criteria:\n\n* Age ≥18 years\n* Evidence of recurrent HGG that in the opinion of the treating team does not represent pseudoprogression and would require surgical resection\n* Karnofsky Performance Score (KPS) ≥ 60%\n* ECOG ≤ 2\n* Life expectancy greater than 12 weeks\n* Adequate liver function defined as ALT, AST, ALP, GGT, bilirubin within 1.5x institutional upper limit of normal\n* Potassium, calcium, and magnesium within normal limits (PCZ cohort)\n* Adequate renal function defined as eGFR levels within 1.5x the institutional upper limit of normal (only for KCZ cohort)\n* Ability to swallow medication\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation.\n* Ability to understand and willingness to sign a written informed consent document\n* Be able to comply with treatment plan, study procedures and follow-up examinations\n\nExclusion Criteria:\n\n* 1\\. Patients may not be receiving any other investigational agents while on study\n* Patients who have known allergy to KCZ, PCZ, or other azoles\n* Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous azole class drugs for a parasitic infection\n* Patients with a history of acute or chronic hepatitis\n* Patients with liver enzymes (ALT, AST, ALP, GGT, Bilirubin) \\>1.5x above normal range for the laboratory performing the test\n* ECG with QT \\> 450 msec (PCZ cohort)\n* Patients taking drugs known to prolong the QT interval (PCZ cohort)\n* Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting KCZ therapy\n* Patients who have taken any azoles within the last 3 months\n* Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.) and who cannot be switched to alternative medications such as keppra (levetiracetam)\n* Uncontrolled intercurrent illness such as chronic hepatitis, acute hepatitis, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements\n* Patients with a history of Addison's disease or other forms of adrenal insufficiency\n* Patient with little or no stomach acid production (achlorhydria) are excluded from the KCZ cohort\n* Pregnant and breast feeding women\n* Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results.\n* Patients who are not available for follow-up assessments or unable to comply with study requirements.\n* Patients who are currently taking medications that induce the metabolism of KCZ or PCZ, such as isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), St. John's wort, among others (see section 5.3 for full details).\n* Patients who are currently taking medications for which the metabolism may be affected by KCZ or PCZ, which include but are not limited to: benzodiazepines (such as alprazolam, midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), some drugs used to treat seizures (such as carbamazepine, phenytoin), some statin drugs (such as atorvastatin, lovastatin, simvastatin)",{"count":139,"type":22},30,[141],"EARLY_PHASE1","High-grade gliomas are the most common and aggressive type of brain cancer. Scientists don't fully understand how they grow and spread, and treatments haven't improved much in recent years. However, it's been discovered that these cancers rely heavily on using glucose to maintain their cancerous traits. In lab tests, drugs from the azole class, which target a key step in glucose metabolism, have shown promise in reducing tumor growth in these cancers. Researchers now want to test two of these drugs, ketoconazole and posaconazole, in patients with recurring high-grade gliomas. A small group of these patients will receive either one or several doses of these drugs before undergoing surgery. During the surgery, doctors will measure how much of the drug is present in the brain. They will also study how the drug affects the tumor, particularly its ability to process glucose. This research aims to provide initial insights into how these drugs work in patients with this type of brain cancer, which could guide future research and treatment strategies.",[144,145,31],"Brain Tumor, Recurrent","Cancer, Advanced",[147],"recurrent high grade glioma, posaconazole, ketoconazole, hexokinase 2 (HK2)","NOT_YET_RECRUITING","2024-03-07",{"date":151,"type":42},"2024-03-08",{"date":153,"type":22},"2024-06-01",{"date":155,"type":22},"2027-06",{"name":157,"class":49},"University Health Network, Toronto",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":171,"conditions":172,"keywords":173,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":50},"100326746","phase-2-neuropsychological-and-oncological-outcomes-in-grade-2-or-3-glioma-patients-undergoing-postoperative-modern-radiotherapy-100326746","NCT03534050","Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy","Neuropsychological and Oncological Outcomes in Grade 2 or 3 Glioma Patients Undergoing Postoperative Modern Radiotherapy - A Prospective Follow-up Study","Inclusion Criteria:\n\n* All patients with infiltrative low-grade gliomas who have received craniotomy plus tumor removal or at least biopsy with pathologic conformation; brain radiation therapy is recommended owning to some high-risk features including subtotal resection (STR) or age at craniotomy older than 40 years old\n* Good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or a general status of Karnofsky Score (KPS) at least 70 %\n\nExclusion Criteria:\n\n* A pathological diagnosis confirmed to be WHO grade IV glioma (i.e., glioblastoma multiforme) or grade I disease (i.e., pilocystic astrocytoma)\n* Radiographic evidence of gliomatosis cerebri\n* Prior cranial irradiation for any reasons","20 Years","84 Years",{"count":168,"type":22},80,[26,170],"PHASE3","Background: Infiltrative low grade gliomas (LGGs) are the most common primary central nervous system malignancies excluding the highest grade glioma, glioblastoma multiforme. Craniotomy with maximal safe tumor resection is endeavored to achieve longer survivals in LGG patients. Unfortunately, due to the infiltrative nature of gliomas and the frequent tumor location in eloquent areas, gross total resection is usually not applicable. According to National Comprehensive Cancer Network 2015 guidelines, postoperative adjuvant radiation therapy (RT) is recommended for most adult patients with low-grade infiltrative LGGs in order to enhance local control and prolong progression-free survival (PFS), except those who are no older than 40 years of age and in whom maximal safe resection is not feasible. However, brain irradiation-related neurocognitive function (NCF) sequelae are potentially and indeed a concern which should not be ignored. In terms of the time course of cranial irradiation-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involve impairments of episodic memory, which has been significantly associated with functions of the hippocampus. This study thus aims to investigate the impact of partial brain irradiation with using contemporary radiotherapeutic techniques on neurocognitive performances, intracranial local control, and progression-free survival in patients with intracranial high-risk grade 2 or 3 gliomas.\n\nMethods: Patients with intracranial high-risk low-grade or grade 3 gliomas will be enrolled to this study once postoperative adjuvant RT is recommended. All eligible and recruited patients should receive baseline functional brain MRI examination and baseline neurobehavioral assessment. Subsequently, partial cranial irradiation will be initiated within one month approximately after enrollment. Brain RT dose will be 5000 - 6000 cGy in 25 - 30 fraction during 5 - 7 weeks. Accordingly, a battery of neuropsychological measures, which includes 7 standardized neuropsychological tests (e.g., executive functions, verbal \\& non-verbal memory, working memory, and psychomotor speed), is used to evaluate neurobehavioral functions for our registered patients. The primary outcome measure is delayed recall, as determined by the change\u002Fdecline in verbal memory or non-verbal memory from the baseline assessment to 4 months after the start of postoperative adjuvant RT.",[31],[63,174,175,176,177,178,179],"Low-Grade Glioma (LGG)","Neurobehavioral Assessments","Neurocognitive Functions (NCF)","Radiation Therapy (RT)","Hippocampus","Progression-Free Survival (PFS)","2023-04-27",{"date":182,"type":42},"2023-05-01",{"date":184,"type":42},"2016-08-01",{"date":186,"type":22},"2026-07-31",{"name":188,"class":49},"Chang Gung Memorial Hospital"]