[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oligodendroglioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oligodendroglioma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,52,94,127,156,178,204,233,260,302,330,372,397,427,447],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100462580","phase-3-sigma-safusidenib-in-idh1-mutant-glioma-maintenance-100462580",false,"NCT05303519","SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","SIGMA","Key Inclusion Criteria for Part 1:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.\n3. The IDH mutation, and other applicable gene\u002Fmolecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified\u002FCollege of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.\n4. Patient has received no more than 2 prior therapies for disease recurrence\u002Fprogression.\n5. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.\n6. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.\n\nKey Inclusion Criteria for Part 2 and 3:\n\n1. Must be ≥18 years old at the time of signing the ICF.\n2. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.\n3. Has adequate hematologic and organ function\n\nKey Inclusion Criteria for Part 2:\n\n1. Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.\n2. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A\u002FB status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.\n3. Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.\n4. Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.\n\nKey Inclusion Criteria for Part 3:\n\n1. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days and no longer than 5 years before the date of enrollment, have not had any other prior anticancer therapy, including chemotherapy and radiotherapy, and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n2. Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.\n3. Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.\n4. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory.\n\nKey Exclusion Criteria for Part 1:\n\n1. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:\n2. Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)\n3. Surgery: within 3 weeks\n4. Radiation therapy: within 12 weeks\n5. Investigational agents: within 5 half-lives for other investigational agents\n6. Patient did receive the prior therapy targeted to IDH1 mutation..\n7. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.\n\nKey Exclusion Criteria for Part 2 and 3:\n\n1. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.\n2. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n3. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.\n4. Evidence of diffuse leptomeningeal disease.\n5. History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n6. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n7. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.\n8. Have a condition that would interfere with, or increase the risk of, study participation.\n\nKey Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent\u002Fadjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.\n\nKey Exclusion Criteria for Part 3:\n\n1\\. Participants may not have received any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including radiotherapy.","ALL","18 Years",{"count":20,"type":21},365,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent\u002Fprogressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.\n\nThe purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.\n\nThe purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.",[27,28,29,30,31,32,33,34],"Glioma","Astrocytoma, Grade IV","IDH1-mutant Glioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Astrocytoma, IDH-Mutant, Grade 2","Oligodendroglioma","Oligodendroglioma, IDH-Mutant and 1p\u002F19q-Codeleted",[36,37,38],"safusidenib","IDH1-mutant glioma","astrocytoma","RECRUITING","2026-06-29",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":43},"2023-06-05",{"date":47,"type":21},"2030-12-01",{"name":49,"class":50},"Nuvation Bio Inc.","INDUSTRY",57,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100528530","phase-2-study-of-olutasidenib-and-temozolomide-in-hgg-100528530","NCT06161974","Study of Olutasidenib and Temozolomide in HGG","Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations","Criteria TarGeT-D study strata definitions\n\n* Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3.\n* Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4.\n* Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG.\n\nInclusion Criteria:\n\n1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:\n\n   1.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:\n   * Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n   * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma.\n   * All other HGG must be WHO Grade 3 or 4.\n\n   1.3) Disease status: There are no disease status requirements for enrollment\n   * Measurable disease is not required. Patients without measurable disease are eligible.\n   * Primary spinal tumor: Patients with a primary spinal HGG are eligible.\n   * Patient must not have metastatic disease.\n2. Inclusion criteria for assignment to TarGeT-D, for all strata:\n\n2.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:\n\n* R132H, R132C, R132S, R132G or R132L.\n* Patients whose tumors harbor other alterations in addition to IDH1 mutation will potentially be eligible following consensus recommendation by the international multidisciplinary molecular screening committee.\n* Patients with IDH2 mutations are not eligible.\n* Patients with oligodendroglioma, IDH-mutant and 1p\u002F19q-codeleted are not eligible.\n\n2.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.\n\n2.3 Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n2.4 Prior Therapy 2.4.1 Surgery, radiation, and\u002For dexamethasone are permissible. Temozolomide administered concurrently with radiotherapy is permissible. Prior administration of bevacizumab is allowed, given at least 42-day washout period is completed prior to beginning treatment on TarGeT-D. No other prior anticancer therapy for HGG will be allowed.\n\n2.4.2 Radiation therapy requirements: RT, delivered via photon or proton beam, must have been administered at a standard dose including 54 Gy in 30 fractions for DIPG, 55-59.4 Gy in 30-33 fractions for other HGG or 45-54 Gy for primary spinal cord HGG. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Study Chair to confirm eligibility prior to study enrollment.\n\n2.4.3 Timing between diagnosis and start of RT: Patients must have started RT \\\u003C 42 calendar days of initial diagnosis defined as the date of diagnostic biopsy or resection; if a patient underwent two upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.\n\n* Patients in pre-maintenance phase must enroll and start treatment no later than 21 calendar days post-completion of RT.\n* Patients not in pre-maintenance phase must enroll and start treatment no later than 35 calendar days post-completion of RT.\n\n2.5 Organ Function Requirements 2.5.1 Adequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm3.\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin \\> 8 g\u002FdL (may be transfused). 2.5.2 Adequate Renal Function Defined as\n* Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 OR\n* Maximum serum creatinine based on age\u002Fgender as follows: 10 to \\\u003C 13 yrs=1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 yrs=1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n2.5.3 Adequate Liver Function Defined as:\n\n* Total bilirubin must be ≤ 1.5 × institutional ULN.\n* AST(SGOT)\u002FALT(SGPT) \\\u003C 3 × institutional ULN.\n* Alkaline Phosphatase \\\u003C 3 × institutional ULN. 2.5.4 Adequate Neurologic Function Defined as:\n\n  * Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not a strong inducer or inhibitor of CYP3A4\u002F5.\n  * Patients must be able to swallow oral medications to be eligible for study enrollment.\n\n2.6. Informed consent: All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy.\n\n   A highly effective contraception method is defined as one that results in a low failure rate (\\\u003C1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:\n   * Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.\n   * Progesterone-only hormonal contraception associated with inhibition of ovulation.\n   * Intra Uterine Device (IUD).\n   * Intra uterine hormone releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner.\n   * Sexual abstinence (avoiding heterosexual intercourse).\n   * The following contraceptive measures are NOT considered effective:\n\n     * Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation.\n     * Male or female condom with or without spermicide.\n     * Cap, diaphragm, or sponge with spermicide.\n2. Using the following types of concomitant medications:\n\n   * Corticosteroids: Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.\n   * Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.\n   * Anti-cancer Agents: Concurrent anti-cancer agents are not allowed with the exception of temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D.\n   * Anticonvulsants: Patients who are receiving enzyme inducing anticonvulsants that are strong inducers of CYP3A4\u002F5 are not eligible.\n   * Strong CYP3A4\u002F5 inducers: Patients who are receiving strong inducers of CYP3A4\u002F5 are not eligible. Strong inducers of CYP3A4\u002F5 should be avoided from 14 days prior to or 5 half-lives (whichever is longer) enrollment to the end of the study.\n   * Patients who are receiving medications known to prolong QTc interval are not eligible\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n3. Other Criteria\n\n   * Infection: Patients who have an uncontrolled infection are not eligible.\n   * Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n   * Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.\n   * Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history.\n   * Patients with prior or ongoing clinically significant illness, medical or psychiatric condition, that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.\n   * Patients with any prior solid organ transplant are not eligible.\n   * Patients with secondary\u002Fradiation-related HGG are not eligible.\n   * Patients with metastatic\u002Fdisseminated HGG who have received CSI are not eligible.","12 Years","39 Years",{"count":62,"type":21},60,[64],"PHASE2","The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.\n\nThe main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.",[67,68,69,28,70,71,72,73,74,75,76,77,78,79,80,81,82,83,33],"High Grade Glioma","Astrocytoma","Astrocytoma, Grade III","Diffuse Intrinsic Pontine Glioma","WHO Grade III Glioma","WHO Grade IV Glioma","Metastatic Brain Tumor","Diffuse Midline Glioma, H3 K27M-Mutant","Thalamus Tumor","Spinal Tumor","IDH1 Mutation","IDH1 R132","IDH1 R132C","IDH1 R132H","IDH1 R132S","IDH1 R132G","IDH1 R132L","2026-06-10",{"date":86,"type":43},"2026-06-12",{"date":88,"type":43},"2025-02-01",{"date":90,"type":21},"2035-06",{"name":92,"class":50},"Rigel Pharmaceuticals",20,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100453871","pro-glio-proton-versus-photon-therapy-in-idh-mutated-diffuse-grade-ii-and-iii-gliomas-100453871","NCT05190172","PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas","PRO-GLIO","1. Patients must be 18 to 65 years old on the day of consent.\n2. IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.\n3. Indication for radiotherapy.\n4. WHO\u002FECOG performance status 0-2.\n5. Ability to undergo MRI.\n6. No significant contrast enhancing tumour (more than 1 or 2 punctate contrast enhancing foci) at the time of randomization. In recurrence patients, no contrast enhancement is allowed unless a new biopsy confirms the diagnosis of IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3.\n7. Ability and willingness to travel to a proton therapy centre if randomized to the proton therapy arm.\n8. Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception during radiotherapy, chemotherapy and 1 year after completion of chemotherapy. Pregnancy is not an ineligibility criterium if radiotherapy is indicated and cannot be postponed\n9. Ability to understand the information about the study and included treatment.\n10. Signed informed consent.\n11. Ability to speak and understand Norwegian or Swedish language.\n\nExclusion Criteria:\n\n1. Prior treatment (except surgery) for diffuse glioma\n2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years\n3. Known CDKN2A\u002FB homozygous deletion\n4. Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up\n5. Body weight \\> 150 kg","65 Years",{"count":103,"type":21},225,[105],"NA","Proton therapy is a powerful tool enabling oncologists to spare normal tissue around the target for irradiation much better than what can be achieved with photon irradiation. The infiltrative nature of IDH-mutated grade II and III diffuse glioma, however, renders proton therapy a potential problem. A randomized controlled trial (RCT) is the only option when trying to ensure that chances of long-term survival are not impaired seeking to reduce unwanted late treatment effects. Non-inferiority of proton therapy compared to photon irradiation is the primary endpoint of the RCT.\n\nHence, PRO-GLIO has two main objectives. First, PRO-GLIO will evaluate if proton therapy is safe in patients with IDH-mutated grade II and III diffuse glioma, showing that survival figures at 2 years from radiotherapy are not poorer in the proton arm than in the photon arm. Second, we want to find the true number of patients in need of rehabilitation in both arms, and evaluate if proton therapy conveys a higher QoL than photon irradiation at 2 years from radiotherapy.",[33,108,109],"Oligodendroglioma, Anaplastic","Diffuse Astrocytoma, IDH-Mutant",[111,112,113,114,115],"proton therapy","radiotherapy","IDH-mutated diffuse grade II astrocytoma","IDH-mutated diffuse grade III astrocytoma","oligodendroglioma","2026-04-27",{"date":118,"type":43},"2026-05-01",{"date":120,"type":43},"2022-01-14",{"date":122,"type":21},"2045-12-31",{"name":124,"class":125},"Oslo University Hospital","OTHER",1,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100626710","phase-2-pre-radiation-chemotherapy-for-newly-diagnosed-high-grade-glioma-100626710","NCT07439172","Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.","A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation","PRC","Inclusion Criteria:\n\n1. Pathologic diagnosis of high-grade glioma\n2. Residual measurable post-operative contrast enhancing tumor\n3. Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)\n4. Ability to provide informed consent\n5. Willingness to comply with all study procedures and availability for the duration of the study\n6. Male or female, aged 18-80.\n7. Karnofsky Performance Status ³70%.\n8. Patients must have the following organ and marrow functions:\n\n   Absolute neutrophil count ≥1,500\u002FµL Platelets ≥100,000\u002FµL Hemoglobin ≥ 9 g\u002FdL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)\u002FALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73m2 APTT\u002FPTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal\n9. Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen\n10. For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration\n11. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner\n12. Patients must have measurable disease as defined by RANO criteria.\n\nExclusion Criteria:\n\n1. Patients receiving any other investigational agents are ineligible.\n2. Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.\n3. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.\n4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, are ineligible.\n5. Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.","80 Years",{"count":137,"type":21},70,[64],"Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read.\n\nFirst, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.",[141,142,68,33],"High Grade Gliomas","Glioblastoma",[27,142,67,144,68,33,145],"Brain Tumor","Temozolomide","NOT_YET_RECRUITING","2026-02-23",{"date":149,"type":43},"2026-02-27",{"date":151,"type":21},"2026-03",{"date":153,"type":21},"2029-09",{"name":155,"class":125},"The Cooper Health System",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":126},"100465767","phase-2-all-trans-retinoic-acid-atra-plus-pd-1-inhibition-in-recurrent-idh-mutant-glioma-100465767","NCT05345002","All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","A Phase 2 Trial of All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","Inclusion Criteria:\n\n1. Prior histopathologically proven diagnosis of astrocytoma (grade 2-4) or oligodendroglioma (grade 2-3) according to the World Health Organization (WHO) 2021 Classification System that is progressive or recurrent following at least one prior alkylating chemotherapy regimen (i.e., temozolomide and\u002For lomustine), +\u002F- radiation therapy\n2. Patient's tumor must have a known mutation in IDH1 or IDH2. IDH1\u002F2 mutation status must be confirmed by DNA sequencing and could have been performed in any CLIA\u002FCAP-certified laboratory. IDH1\u002F2 mutational testing could have been performed on patient's tumor either at initial diagnosis or on a subsequent recurrent tumor.\n3. Safety Run-In and Phase 2 (Arm A and Arm B) patients:\n\n   * All Safety Run-In and Phase 2 patients: patients with any contrast-enhancing tumor must have measurable disease per RANO criteria (defined by at least 1cmx1cm of contrast-enhancing tumor). Patients with exclusively non-enhancing tumors must have least a 25% increase in bi-dimensional product of FLAIR signal abnormality (measurable disease) compared to the patient's best MRI scan (smallest bi-dimensional product of FLAIR signal abnormality) obtained following completion of the patient's most recent line of therapy\n   * Safety Run-In: Must have failed temozolomide OR another alkylator (e.g. lomustine, procarbazine, carmustine). May have failed an unlimited number of prior systemic regimens, +\u002F- prior radiotherapy.\n   * Arm A: Must have failed temozolomide AND another alkylator (e.g. lomustine, procarbazine, carmustine). May have failed an unlimited number of prior systemic regimens, +\u002F- prior radiotherapy.\n   * Arm B: Must have failed temozolomide OR another alkylator (maximum one prior chemotherapy regimen) +\u002F- prior radiotherapy, AND must have gone at least 12 months since last treatment (chemotherapy or radiotherapy).\n4. Surgical patients (Arm C and Arm D):\n\n   * Must have clinical indication for surgical resection of the suspected recurrent\u002Fprogressive tumor, as determined by patient's care providers; measurable disease is not required\n   * 5-aminolevulinic acid (5-ALA) is not allowed for intraoperative tumor visualization due to the photosensitizing agent interaction with ATRA\n   * Patient may have had an unlimited number of relapses and prior therapy regimens\n5. Patients must be able to undergo MRI of the brain with gadolinium. Patients must be maintained on a stable or decreased dose of corticosteroid regimen (no increase for 5 days) prior to this baseline MRI.\n6. Patients must have recovered from severe toxicity of prior therapy; the following intervals from previous treatments are required to be eligible:\n\n   * 12 weeks from completion of radiation\n   * 6 weeks from a nitrosourea cytotoxic chemotherapy\n   * 3 weeks from a non-nitrosourea cytotoxic chemotherapy\n   * 4 weeks from any investigational (not Food and Drug Administration \\[FDA\\]-approved) agents, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter\n   * 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g. abemaciclib, olaparib, etc)\n7. If patient is on systemic corticosteroids to treat brain edema and\u002For brain edema-related symptoms, the dose must be 2mg of dexamethasone (or equivalent) daily or less for a minimum of 5 days prior to first dose of retifanlimab.\n8. Patients must be able to swallow oral medications\n9. Age 18 or older\n10. Karnofsky performance status greater than or equal to 60\n11. Life expectancy \\>3 months\n12. Adequate organ and marrow function:\n\n    * Total bilirubin \\\u003C1.5 x upper limit of normal (ULN) (except patients with suspected Gilbert's Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion)\n    * ALT and AST ≤ 2.5x ULN\n    * Calculated CrCl ≥ 30 ml\u002Fmin (glomerular filtration rate can also be used in place of CrCl)\n    * Absolute Neutrophil count ≥1,500\u002FuL\n    * Platelets ≥ 100,000\u002FuL\n    * Hemoglobin ≥ 9 g\u002FdL\n13. Reproductive Status\n\n    1. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 7 days prior to the start of study drug.\n    2. b) Women must agree to not breastfeed during the study or for 180 days after the last dose of study treatment\n    3. WOCBP must agree to use an adequate method to avoid pregnancy (as defined below) from the time of study screening through 180 days from last dose of study drug\n    4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (as defined below) starting with the first dose of study drug through 180 days after the last dose of study\n    5. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, these WOCBP must still undergo pregnancy testing as described in this section.\n\n    At a minimum, participants of childbearing potential who are sexually active and their partners must agree to the use of a highly effective form of contraception (as defined below) throughout their participation beginning with the time of consent, during the study treatment, and for 180 days after last dose of study treatment(s).\n\n    HIGHLY EFFECTIVE METHODS OF CONTRACEPTION:\n    * Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) by WOCBP subject or male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug\n    * Nonhormonal IUDs\n    * Bilateral Tubal ligation\n    * Vasectomy\n    * Sexual Abstinence\n\n      * It is not necessary to use any other method of contraception when complete abstinence is elected.\n      * WOCBP participants who choose complete abstinence must continue to have pregnancy tests.\n      * Acceptable alternate methods of highly effective contraception must be discussed in the event that the WOCBP participants chooses to forego complete abstinence.\n14. Participant must, in the opinion of the Investigator, be able to comply with study procedures\n15. Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent (or have legally authorized representative sign on patient's behalf if patient physically unable to sign consent due to neurologic deficit)\n\nExclusion Criteria:\n\nAny of the following would exclude the subject from participation in the study:\n\n1. Contrast-enhancing tumor in brainstem or spinal cord (subjects do not need spinal MRI for screening, but known spinal cord tumor is exclusionary)\n2. Diffuse leptomeningeal disease\n3. Patients who have received bevacizumab within the last 3 months are ineligible\n4. Patients with clinically significant mass effect or midline shift (e.g., 1-2 cm of midline shift)\n5. Use of any immunosuppressive medication other than steroids, including but not limited to antimetabolites, calcineurin inhibitors, and\u002For anti-TNF agents within six months of start of study drug\n6. Prior diagnosis of immunodeficiency\n7. Prior solid organ or bone marrow transplantation\n8. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n\n   * Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n   * Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n   * Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n   * Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n\n   EXCEPTIONS: Patients with the following autoimmune diseases may participate: type I diabetes mellitus, hypothyroidism only requiring hormone replacement, Grave's disease that is previously treated with thyroidectomy or radioiodine, celiac disease with symptoms controlled with a gluten-free diet.\n9. Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n10. Immune related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n11. Known active hepatitis B virus (HBsAg reactive) or active hepatitis C virus (HCV RNA detectable by PCR)\n12. Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy\n13. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded from this trial. Otherwise, patients with prior or concurrent malignancy are eligible.\n14. Any serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection that, in the opinion of the investigator, would put the subject at undue risk from the study treatment.\n15. Patients with uncontrolled or significant cardiovascular disease including, but not limited to, any of the following are ineligible:\n\n    * Myocardial infarction or uncontrolled angina within 90 days prior to consent\n    * History of clinically significant arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n    * History of cardiomyopathy, pericarditis, significant pericardial effusion, myocarditis, or New York Heart Association (NYHA) functional class III-IV congestive heart failure\n16. Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (e.g., antihistamines and corticosteroids)\n17. Known allergy or hypersensitivity to any component of retifanlimab or formulation components.\n18. Known allergy or hypersensitivity to all-trans retinoic acid (tretinoin), any of its components, or other retinoids\n19. Prisoners or subjects who are involuntarily incarcerated\n20. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness\n21. Pregnant women are excluded\n22. Has received a live vaccine within 28 days before the planned start of study treatment\n\n    Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n23. Participant must not be simultaneously enrolled in any interventional clinical trial",{"count":164,"type":21},55,[64],"This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response.",[27,168,68,33],"IDH Mutation","2026-02-19",{"date":171,"type":43},"2026-02-20",{"date":173,"type":43},"2022-11-16",{"date":175,"type":21},"2028-06-01",{"name":177,"class":125},"Stephen Bagley, MD, MSCE",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100464732","phase-3-a-clinical-study-to-improve-brain-function-and-quality-of-life-of-patients-with-newly-diagnosed-brain-tumors-gliomas-100464732","NCT05331521","A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).","Improvement of Functional Outcome for Patients With Newly Diagnosed Grade 2 or 3 Glioma With Co-deletion of 1p\u002F19q - IMPROVE CODEL: the NOA-18 Trial","ImproveCodel","Inclusion Criteria:\n\n1. Histologically confirmed, newly diagnosed CNS WHO grade 2 or 3 glioma.\n2. Tumor carries an isocitrate dehydrogenase (IDH) mutation (determined by immunohistochemistry (IHC) and\u002For deoxyribonucleic acid (DNA) sequencing).\n3. Tumor is co-deleted for 1p\u002F19q (determined by copy number variations, fluorescence in situ hybridization (FISH), multiplex ligation-dependent probe amplification (MLPA) or other appropriate methods).\n4. Biopsy (with sufficient tissue for molecular pathology) or resection.\n5. Age: ≥18 years.\n6. Karnofsky Performance status (KPI) ≥60%.\n7. Life expectancy \\>6 months.\n8. Availability of formalin-fixed paraffin-embedded (FFPE) or fresh-frozen tissue and ethylenediamine tetraacetic acid (EDTA) blood for biomarker research.\n9. Standard magnetic resonance imaging (MRI) ≤ 72 h post-surgery according to the present national and international guidelines.\n10. Craniotomy or intracranial biopsy site must be adequately healed.\n11. ≥ 2 weeks and ≤ 3 months from surgery without any interim radio- or chemotherapy or experimental intervention.\n12. Willing and able to comply with regular neurocognitive and health-related quality of life tests\u002Fquestionnaires.\n13. Indication for postsurgical cytostatic\u002F-toxic therapy.\n14. Written Informed consent.\n15. Female patients with reproductive potential have a negative pregnancy test (serum or urine) day -6 until day 0 of screening (and 3 days prior to first IMP-intake or RT). Female patients are surgically sterile or agree to use adequate contraception during the period of therapy and 7 months after the end of study treatment, or women have been postmenopausal for at least 2 years.\n16. Male patients are willing to use contraception\n\nExclusion Criteria:\n\n1. Participation in other ongoing interventional clinical trials.\n2. Inability to undergo MRI.\n3. Abnormal (≥ Grade 2 CTCAE v5.0 laboratory values for hematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal function (serum creatinine).\n4. Clinically active tuberculosis; known HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV) infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue (e.g. rabies).\n5. Any prior anti-cancer therapy or co-administration of anti-cancer therapies other than those administered\u002Fallowed in this study. History of low-grade glioma that did not require prior treatment with chemotherapy or radiotherapy is not an exclusion criterion.\n6. Immunosuppression, not related to prior treatment for malignancy.\n7. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years.\n8. Any clinically significant concomitant disease (including hereditary fructose intolerance) or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study.\n9. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and\u002For follow-up procedures; those conditions should be discussed with the patient before trial entry.\n10. Pregnancy or breastfeeding.\n11. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. (E.g.: In the discretion of the investigator patients are allowed to take part in the study even if they suffer from celiac disease: Cecenu contains very small amounts of gluten (from wheat starch). It is considered gluten-free and is tolerated by patients suffering from celiac disease. One capsule contains no more than 4 micrograms of Gluten.)\n12. QTc time prolongation \\>500 ms.\n13. Patients under restricted medication for procarbazine, lomustine, vincristine and temozolomide.\n14. Liver disease characterized by:\n\n    1. ALT or AST (≥ Grade 2 CTCAE v5.0) confirmed on two consecutive measurements OR\n    2. Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices (≥ Grade 2 CTCAE v5.0) OR\n    3. Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis.\n15. Known uncorrected coagulopathy, platelet disorder, or history of non-drug induced thrombocytopenia.\n16. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; autoimmune-related hypothyroidism (patients on a stable dose of thyroid replacement hormone are eligible for this study) and type I diabetes mellitus (patients on a stable dose of insulin regimen are eligible for this study).\n17. Vaccination with life vaccines during treatment and 4 weeks before start of treatment.\n18. Existing neuromuscular diseases, especially neural muscular atrophy with segmental demyelination (demyelinising form of Charcot-Marie-Tooth syndrome).\n19. Chronic constipation and subileus.\n20. Combination treatment with mitomycin (risk of a pronounced bronchospasm and acute shortness of breath).\n21. Hypersensitivity to dacarbazine (DTIC).\n22. Patients with hereditary galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption (Temodal contains Lactose).\n23. Patients with clinical wheat allergy.",{"count":187,"type":21},406,[24],"Oligodendrogliomas in the novel edition of the Central Nervous System (CNS) World Health Organization (WHO) classification are now molecularly defined by isocitrate dehydrogenase (IDH)1 or IDH2 mutations and 1p\u002F19q co-deletion. The prognosis of these molecularly defined tumors is to be determined in new series since survival data from older histology-based studies and population-based registries are confounded by the inclusion of 20-70% not molecularly matching subsets. Also, the optimal treatment is a matter of ongoing investigations. An extensive, but safe surgery is associated with improved outcome as is the addition of chemotherapy with procarbazine, CCNU (lomustine), and vincristine (PCV) to the partial brain radiotherapy (RT). However, the exact timing of postsurgical therapy especially for tumors of the WHO grade 2 and acknowledging some variability in grading as well as the choice of chemotherapy, temozolomide instead of PCV (CODEL: NCT00887146 randomizing CNS WHO grade 2 and 3 oligodendrogliomas to chemoradiation(CHRT)therapy with PCV or with temozolomide) or the need for primary radiotherapy RT are subjects of clinical studies (POLCA: NCT02444000 randomizing patients with newly diagnosed CNS WHO grade 3 oligodendrogliomas to standard CHRT with PCV or PCV alone). Given the young age of patients with CNS WHO grade 2 and 3 oligodendrogliomas and the relevant risk of neurocognitive, functional and quality-of-life impairment with the current aggressive standard of care treatment, chemoradiation with PCV, of the tumor located in the brain optimizing care is the major challenge.\n\nNOA-18\u002FIMPROVE CODEL aims at improving qualified overall survival (qOS) for adult patients with CNS WHO grade 2 and 3 oligodendrogliomas by randomizing between standard chemoradiation with up to six six-weekly cycles with PCV and six six-weekly cycles with lomustine and temozolomide (CETEG), thereby delaying radiotherapy (RT) and adding the chemoradiotherapy (CHRT) concept at progression after initial radiation-free chemotherapy, allowing for an effective salvage treatment and delaying potentially deleterious side effects. QOS represents a new concept and is defined as OS without functional and\u002For cognitive and\u002For quality of life (QOL) deterioration regardless whether tumor progression or toxicity is the main cause.",[33],[192,193,145],"Radiotherapy","Chemotherapy","2026-01-30",{"date":196,"type":43},"2026-02-03",{"date":198,"type":43},"2021-04-07",{"date":200,"type":21},"2033-03-31",{"name":202,"class":125},"University Hospital Heidelberg",19,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100416431","phase-3-a-randomized-trial-of-delayed-radiotherapy-in-patients-low-grade-oligodendrogliomas-requiring-a-treatment-other-than-surgery-100416431","NCT04702581","A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery","A Randomized Trial of Delayed Radiotherapy in Patients 1p\u002F19q Codeleted Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery","POLO","Inclusion Criteria:\n\n* Tumor is co-deleted for 1p and 19q based and IDH-mutant (IDH1 or IDH2) according to local diagnosis\n* Histological confirmation of low-grade oligodendroglioma by central pathological review according to WHO 2016 classification\n* Age ≥ 18 years\n* Patients with one or several prior surgical procedure for a low-grade oligodendroglioma and who undergo a resurgery are eligible if they have not received prior radiotheray or chemotherapy and if the last histological diagnosis is a low-grade oligodendroglioma prior use of specific HDI prohibitions is permitted\n* Patients who undergo an initial follow-up after surgery or re-surgery are eligible if there is no evidence of anaplastic transformation on MRI (no new contrast enhancement, no obvious modification of the growth rate)\n* Patients requiring an oncological treatment other than surgery because of one or more of the following characteristics:\n\n  * Progressive disease defined as documented growth prior to inclusion\n  * Symptomatic disease defined as the presence of neurological or cognitive symptoms or refractory seizures defined as having both persistent seizures interfering with everyday life activities other than driving a car and three lines of anti-epileptic drug regimen had not worked, including at least one combination regimen.\n  * Age ≥ 40 and any surgical therapy\n  * Age \\\u003C 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection)\n* Willing and able to complete neurocognitive examination and the QOL\n* Karnofsky performance status ≥ 60\n* Laboratory values obtained between 21 days before inclusion andrandomization, respecting the following criteria:\n* Absolute neutrophil count (ANC) ≥1500 \u002Fmm3\n* Platelet count ≥100,000 \u002F mm3\n* Hemoglobin \\> 9.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* SGOT (AST) ≤ 3 x ULN\n* Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.\n* Provide informed written consent\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Men or women of childbearing potential who are unwilling to employ adequate contraception for up to 6 months following the completion of PCV.\n* Received any prior radiation therapy or chemotherapy for any CNS neoplasm.\n* Co-morbid systemic illnesses or other severe concurrent disease which 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* Concomitant serious immunocompromised status (other than that related to concomitant steroids).\n* Uncontrolled intercurrent illness 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 (except specific inhibitors of IDH)\n* Other active malignancy within 5 years of registration. Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.\n* Contra-indication to CCNU: hypersensitivity to CCNU, wheat allergy, association to yellow fever vaccin\n* Contra-indication to Procarbazine: severe renal failure, severe hepatic failure, hypersensitivity to procarbazine, association to yellow fever vaccin\n* Contra-indication to Vincristine: hypersensitivity to vincristine, neuromuscular disorder (for example demyelinating Charcot-Mary Tooth neuropathy), severe renal failure, severe hepatic failure.\n* Not depending from the french system of health assurance",{"count":213,"type":21},280,[24],"Because of their prolonged survival, patients with 1p\u002F19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival.",[33,217,218],"Low-grade Oligodendroglioma","1p19q Codeletion",[220,112,221,222],"low-grade oligodendroglioma","PCV","neurocognitive deterioration","2026-01-28",{"date":225,"type":43},"2026-01-29",{"date":227,"type":43},"2021-12-07",{"date":229,"type":21},"2030-12",{"name":231,"class":125},"Hospices Civils de Lyon",26,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":126},"100410394","phase-2-chemotherapy-and-radiation-therapy-for-the-treatment-of-idh-wildtype-gliomas-or-non-histological-molecular-glioblastomas-100410394","NCT04623931","Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas","Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)","Inclusion Criteria:\n\n* Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma\n* IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma \\[GBM\\])\n* History \\& physical exam, and Karnofsky performance status (KFS) of \\>= 70 within 30 days prior to enrollment\n* Post-operative magnetic resonance imaging (MRI) with contrast is mandatory and necessary for radiation therapy (RT) planning\n* Thin-slice (\\\u003C 1.5 mm) three-dimensional (3D) T1 pre and post contrast and axial T2\u002Ffluid-attenuated inversion recovery (FLAIR) sequences for planning purposes are highly encouraged to obtain.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3 (within 60 days prior to registration)\n* Platelets \\>= 100,000 cells\u002Fmm\\^3 (within 60 days prior to registration)\n* Hemoglobin \\>= 10.0 g\u002Fdl (within 60 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable)\n* Bilirubin =\\\u003C 1.5 upper limit of normal (ULN) (within 60 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 60 days prior to registration)\n* Blood urea nitrogen (BUN) \\\u003C 30 mg\u002Fdl (within 60 days prior to registration)\n* Serum creatinine \\\u003C 1.5 mg\u002Fdl (within 60 days prior to registration)\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of metastatic disease; if applicable\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity or cervix are permissible)\n* Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist\n* Prior chemotherapy or radiotherapy for any brain tumor\n* Histologic diagnosis of gliosarcoma World Health Organization (WHO grade IV) or pilocytic astrocytoma (WHO grade I)\n* Multicentric glioblastoma\n* Leptomeningeal disease\n* Inability to undergo MRI with and without contrast\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment\n  * Transmural myocardial infarction within the last 6 months prior to registration. Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \\>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue)\n\n    • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration\n  * Serious and inadequately controlled arrhythmia at step 2 registration\n  * Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\n  * Human immunodeficiency virus (HIV) positive with CD4 count \\\u003C 200 cells\u002Fmicroliter. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed\n* Any other severe immunocompromised condition\n* Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity\n* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)\n* Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy",{"count":241,"type":21},40,[64],"This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.",[245,246,247,248,142,249,33,250,71],"Anaplastic Astrocytoma, IDH-Wildtype","Anaplastic Oligoastrocytoma","Anaplastic Oligodendroglioma","Diffuse Astrocytoma, IDH-Wildtype","Oligoastrocytoma","WHO Grade II Glioma","2026-01-12",{"date":253,"type":43},"2026-01-14",{"date":255,"type":43},"2020-01-30",{"date":257,"type":21},"2026-12-31",{"name":259,"class":125},"M.D. Anderson Cancer Center",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":292,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":126},"100404034","phase-1-phase-i-study-of-oral-onc206-in-recurrent-and-rare-primary-central-nervous-system-neoplasms-100404034","NCT04541082","Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms","A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms","Inclusion Criteria:\n\nPatients must meet all the following criteria to participate in the study:\n\n1. Patients aged ≥18 years with a recurrent, primary CNS neoplasm. For all cohorts, patients must have a histologically confirmed primary CNS neoplasm. Primary CNS neoplasms in this study include, but are not limited to, the following: glioblastoma and glioblastoma histologic subtypes, gliosarcoma, primary CNS sarcomas, anaplastic glial neoplasms including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed neuronal-glial tumors, and pilocytic astrocytoma with anaplastic features, diffuse astrocytoma, oligodendroglioma, gliomatosis cerebri, pleomorphic xanthoastrocytoma, anaplastic pleomorphic xanthoastrocytoma, diffuse midline gliomas and histone mutated gliomas (NOTE: Patients with H3 K27M-mutant diffuse gliomas are excluded unless the primary tumor is located in the pons or spinal cord, or the patient has completed front line radiation or received ONC201 therapy prior to 01 January 2023), ependymoma, anaplastic ependymoma, and all ependymoma subtypes, medulloblastoma and all medulloblastoma subtypes, atypical teratoid\u002Frhabdoid tumor, primary CNS embryonal\u002Fprimitive neuroectodermal tumors, atypical and anaplastic meningiomas, choroid plexus tumors, and pineal region tumors.\n2. Patients must have recurrent and measurable disease as defined by RANO criteria, using either the HGG and\u002For LGG RANO criteria based on tumor type, after having received established standard of care treatment for their disease and have no standard treatment options available as determined by the investigators. There is no limit on the number of total recurrences or prior therapies. However, prior therapies with known clinical benefit (including radiation) for specific tumor types are required. If patients are deemed ineligible for such therapies in the opinion of the Investigator, the Investigator must document the reason the patient is considered ineligible.\n3. Patients must have a Karnofsky Performance Score (KPS) of greater than or equal to 70. Patients with severe paraparesis\u002Fparaplegia who need minimal assistance for self-care due to their motor deficit but are otherwise functionally independent will be considered eligible.\n4. (Inclusion Criterion #4 was removed in Amendment 3.)\n5. Patients must not have received prior investigational or approved cytotoxic chemotherapy within 28 days prior to the first dose of study drug (Cycle 1, Day 1); 42 days in the case of nitrosoureas; 42 days in the case of bevacizumab; 28 days or 5 half-lives (whichever is less; but not less than 14 days) in case of investigational or approved molecularly targeted agent; 14 days in the case of radiotherapy.\n6. (Inclusion Criterion #6 was removed in Amendment 7.)\n7. Patients with AEs Grade ≥2 related to prior therapies (chemotherapy, radiotherapy, and\u002For surgery) must have all their AEs resolved prior to the first dose of study drug (Cycle 1, Day 1), except for alopecia or neuropathy; Grade 1 or 2 lymphopenia is allowed.\n8. Patients must not have undergone major surgery 4 weeks prior to the first dose of study drug (Cycle 1, Day 1) and must have completely recovered from any surgery (minor surgical procedures such as skin biopsies and port placement done on an outpatient basis do not require a waiting period).\n9. Patients must have normal organ and marrow function as defined below:\n\n   * Absolute neutrophil count (ANC) ≥1,500\u002FmcL.\n   * Platelets ≥100,000\u002FmcL.\n   * Hemoglobin ≥9.0 mg\u002FdL without transfusion in 2 prior weeks.\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert's syndrome may be included with total bilirubin \\>1.5 × ULN if direct bilirubin is ≤1.5 × ULN).\n   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × ULN.\n   * Measured or estimated creatinine clearance (CLcr) ≥40 mL\u002Fminute for patients with creatinine levels above normal. CLcr will be calculated by the Cockcroft-Gault equation for renal function.\n10. (Inclusion Criterion #10 was removed in Amendment 3)\n11. Patients must provide a tumor specimen (paraffin-embedded block and\u002For frozen tissue) from a prior resection or biopsy available that is sufficient to perform biomarker assays, ≥15 unstained slides for immunohistochemistry (IHC) analysis must be received by the NOB by the first dose of study drug (Cycle 1, Day 1). For patients with ≥10 to \\\u003C15 slides, eligibility will be reviewed on a case-by-case basis.\n12. Dependent upon dose level assignment and drug formulation (i.e., capsules versus powder in bottle \\[PIB\\]), patients must be able to either swallow oral capsules or swallow liquids.\n13. Patients must provide study-specific informed consent prior to enrollment. No Durable Power of Attorney or Next of Kin can provide initial consent.\n14. Patients must be able to tolerate a magnetic resonance imaging (MRI) study with intravenous gadolinium contrast.\n15. (Inclusion Criterion #15 was removed in Amendment 6)\n16. Patients must have a negative COVID-19 test within 72 hours of the first dose of study drug (Cycle 1, Day 1). Patients who had documented COVID-19 infection within 90 days of treatment but more than 20 days from infection do not need to be tested.\n17. (Inclusion Criterion #17 was removed in Amendment 6)\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. (Exclusion Criterion #1 was removed in Amendment 3)\n2. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC206 (e.g., ONC201) or its excipients.\n3. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n4. Patients who are unable or unwilling to abide by the study protocol or cooperate fully with the Investigator.\n5. Patients with a known HIV-positive test on combination anti-retroviral therapy are ineligible for this initial first-in-human trial because of the potential for PK interactions with ONC206.\n6. Patients with active cardiac disease, including any of the following:\n\n   * Corrected QT interval (QTc) ≥470 msec on screening electrocardiogram (ECG; using the QTc by Fridericia's \\[QTcF\\] formula);\n   * Angina pectoris that requires the use of anti-anginal medication;\n   * Ventricular arrhythmias except for benign premature ventricular contractions;\n   * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\n   * Conduction abnormality requiring a pacemaker;\n   * Valvular disease with documented compromise in cardiac function; and\u002For\n   * Symptomatic pericarditis.\n7. Patients with a history of cardiac dysfunction including any of the following:\n\n   * Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction function;\n   * History of documented congestive heart failure (New York Heart Association functional classification III-IV); and\u002For\n   * Documented cardiomyopathy.\n8. Patients who have had an ischemic or hemorrhagic stroke in the last 3 months. If the patient has had a recent tumor resection, cerebral ischemic or hemorrhagic changes that occur peri operatively are not an exclusion.\n9. Patients with refractory epilepsy are excluded. Patients with primarily or secondarily generalized seizures in the 28 days prior to study enrollment will be excluded. Peri-operative seizures, defined as seizures occurring within the 7 days after a stereotactic biopsy, open biopsy, or surgical resection will not be an exclusion as long as the patient has had no generalized seizures starting 8 days after the surgical procedure. Patients with prior seizures must be on stable doses of 1 or 2 seizure medications for at least 14 days prior to study enrollment.\n10. Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ONC206 (uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n11. Patients who have been treated with any hematopoietic colony-stimulating growth factors (CSFs) (e.g., granulocyte-CSF, granulocyte-macrophage-CSF) ≤2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued.\n12. Patients who are currently taking therapeutic doses of warfarin sodium or any other coumadin derivative anticoagulant.\n13. Patients who are taking strong inhibitors or inducers of cytochrome P450 (CYP) 3A4, 2D6, 1A2, 2C9, and 2C19 within at least 14 days prior to the first dose of study drug (Cycle 1, Day 1); these medications are excluded throughout the study.\n14. Women who are pregnant or breast feeding.\n15. Women of child-bearing potential with a positive serum pregnancy test ≤72 hours prior to the first dose of study drug (Cycle 1, Day 1).\n16. Patients who are receiving concomitant standard and\u002For investigational anti-cancer therapy.\n17. Patients with alcohol or substance abuse which, in the opinion of the Investigator, would interfere with compliance or safety.\n18. Patients with the presence of any other serious and\u002For unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with patients' safety, obtaining informed consent or compliance to the study procedures as determined by the Investigators.\n19. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, or men who do not agree to use highly effective contraception during treatment and for 16 additional weeks after the final dose of study drug.\n\n    Highly effective contraception is defined as either:\n    * True abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Sterilization: Females must have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n    * Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * If patients are not practicing true abstinence and\u002For if the patient or sexual partner have not had a sterilization procedure as listed above, patients and their sexual partners must follow double barrier contraception in accordance with the guidelines for contraception below:\n\n      * Females of childbearing potential:\n\n        * Must use an intrauterine device or intrauterine system, during dosing of any study agent and for 16 weeks after final dose of study drug; or\n        * Must use a double barrier method of contraception: use of an occlusive cap (diaphragm or cervical\u002Fvault cap) with spermicide for women combined with use of a condom by their male partners capable of conceiving offspring.\n      * Males capable of conceiving offspring must use condoms during dosing of study agent and for an additional 16 weeks after final dose of study drug.\n\n    Note: Oral, implantable, or injectable contraceptives may be affected by CYP interactions, and are therefore not considered effective for this study.\n20. Previous receipt of ONC201, placebo, or blinded study drug from an ONC201 clinical study, or from any other source for H3 K27M-mutant diffuse glioma on or after 01 January 2023.",{"count":268,"type":21},102,[270],"PHASE1","The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.",[273,142,274,247,275,276,33,277,278,279,74,280,281,282,283,284,285,286,287,288,289,290,291],"Central Nervous System Neoplasms","Gliosarcoma, Adult","Anaplastic Astrocytoma","Pilocytic Astrocytoma","Gliomatosis Cerebri","Pleomorphic Xanthoastrocytoma","Anaplastic Pleomorphic Xanthoastrocytoma","Ependymoma","Ependymoma, Anaplastic","Medulloblastoma","Teratoid Rhabdoid Tumor","Neuroectodermal Tumors, Primitive","Neuroectodermal Tumors","Anaplastic Meningioma","Atypical Meningioma","Choroid Plexus Neoplasms","Pineal Tumor","Diffuse Astrocytoma","Glial Tumor",[142,275,247,290,33],"2025-12-17",{"date":295,"type":43},"2025-12-18",{"date":297,"type":43},"2020-10-26",{"date":299,"type":21},"2026-12",{"name":301,"class":50},"Jazz Pharmaceuticals",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":309,"sex":17,"minAge":310,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":126},"100512774","phase-1-treatment-of-relapsedrefractory-intracranial-glioma-in-patients-under-22-years-of-age-100512774","NCT05956821","Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Phase I\u002FII Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Inclusion Criteria:\n\n* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)\n* Must have at least one confirmed and evaluable tumor site\n* Must have a Karnofsky or Lansky performance status ≥60%.\n* No chemotherapy for three weeks prior to treatment\n* Patients must have adequate hematologic reserve with absolute neutrophils≥1000\u002Fmm3 and platelets ≥100,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\\\u003C2.5x IUNL and creatinine\\\u003C1.5x IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL\n* Growth factor(s): Must not have received within 1 week of entry onto this study\n* Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.\n* Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients or their parents\u002Fguardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n* Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating\n* Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study\n* Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring",true,"1 Year","21 Years",{"count":93,"type":21},[270,64],"This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \\\u003C 22 years of age.",[316,275,317,33,318,70,319,320],"Glioblastoma Multiforme","Fibrillary Astrocytomas","Diffuse Intrinsic Brainstem Glioma","DIPG Brain Tumor","H3 K27M","2025-12-04",{"date":323,"type":43},"2025-12-08",{"date":325,"type":43},"2025-06-19",{"date":327,"type":21},"2029-12-01",{"name":329,"class":125},"University of Miami",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":352,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":126},"100587627","hobscotch-ca-home-based-self-management-and-cognitive-training-changes-lives-in-brain-cancer-100587627","NCT06930846","HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)","HOBSCOTCH-CA","CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion\u002Fexclusion criteria. Inclusion Criteria 2. - 5. and Exclusion Criteria 1. - 3. will be confirmed by referring providers. Participants who learn about the study here and elsewhere will be instructed on how to confirm their eligibility with their provider.\n\nInclusion Criteria for CA Participant:\n\n1. 18 + years\n2. Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)\n3. Diagnosis of primary brain tumor with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT or MRI), confirmed by histopathological examination (Note: some patients being treated for meningioma may be treated with radiotherapy without need for initial histopathologic confirmation)\n4. Patients undergoing surgical and\u002For radiation therapy will have completed their treatment at least 3 months prior to being enrolled in trial (Note: patients receiving chemotherapy or other systemic therapy will be included)\n5. Stable on all CNS acting medications for one month prior to enrollment\n6. Subjective cognitive complaints\n7. Literate and proficient in English\n8. Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8\n\nExclusion Criteria for CA Participant:\n\n1. Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n2. Acute psychiatric disorder or substance abuse\n3. Patients with glioblastoma (GBM)\n\nInclusion Criteria for CA Participant Caregiver:\n\n1. Age 18 +\n2. Caregiver to a patient with a confirmed diagnosis of brain cancer\u002Ftumor survivor\n3. CA Subject has given permission for their caregiver to participate\n4. Literate and proficient in English\n5. Internet access (for Pre-HOBSCOTCH and Session 1)\n6. Telephone access (for Session 8)\n\nExclusion Criteria for CA Participant Caregiver:\n\n1. Significant visual impairment precluding reading or writing\n2. No reliable telephone or internet access",{"count":338,"type":21},125,[105],"The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer\u002Ftumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants.\n\nInvestigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.\n\nHOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a \"pre\" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).",[342,144,343,344,345,33,346,347,348,349,350,351],"Brain Cancer","Brain Neoplasms","Primary Brain Tumor","Low-grade Glioma","Meningioma","Low Grade Astrocytoma","Cognitive Dysfunction","Memory Impairment","Memory Disorders","Memory Dysfunction",[353,354,355,356,357,358,359,360,361,362],"Brain cancer survivor","Brain tumor survivor","Cognition","Self-management","Cognitive training","Memory disorders","Cognitive remediation","Caregiver","Caregiver burden","Mindfulness","2025-11-18",{"date":365,"type":43},"2025-11-21",{"date":367,"type":43},"2025-11-03",{"date":369,"type":21},"2028-12",{"name":371,"class":125},"Dartmouth-Hitchcock Medical Center",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":126},"100592104","fearless-in-neurooncology-100592104","NCT06989086","FearLess in NeuroOncology","FearLess in Neuro-Oncology","Inclusion Criteria:\n\nPatients:\n\n* Self-report a diagnosis of a primary malignant brain tumor (grade II-IV)\n* \\>2 weeks post-cranial resection or biopsy\n* Elevated Fear of Recurrence Distress Rating\n* Primarily English speaking\n* \\>\u002F= 18 years of age at the time of enrollment\n\nCaregivers:\n\n* nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV)\n* Elevated Fear of Recurrence Distress Rating\n* Primarily English speaking\n* \\>\u002F= 18 years of age at the time of enrollment\n\nExclusion Criteria:\n\nPatient \u002F Caregiver Exclusion:\n\n* Cognitive impairment that might prohibit active intervention engagement\n* Inability to understand and provide informed consent\n* Inability to attend virtual sessions due to unstable or no internet connection",{"count":380,"type":21},112,[105],"The overarching goal of this project is to assess the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design to finalize the protocol of FearLess in primary malignant brain tumor patients and caregivers",[384,385,68,33,360],"Primary Malignant Brain Tumor","Glioblastoma (GBM)",[387],"brain tumor","2025-09-02",{"date":390,"type":43},"2025-09-09",{"date":392,"type":43},"2025-06-24",{"date":394,"type":21},"2028-12-31",{"name":396,"class":125},"Virginia Commonwealth University",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":405,"studyType":406,"phases":4,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100412277","proton-therapy-research-infrastructure--protrait--neuro-oncology-100412277","NCT04648462","Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology","Inclusion Criteria:\n\n1. All brain tumors with a favorable prognosis (median survival \\> 10 year)\n2. Age ≥ 18 years\n3. ECOG performance status 0 - 1 \u002F Karnofsky performance status 80 - 100\n4. No - minimal neurocognitive impairment\n5. Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi)\n6. Informed consent\n\nExclusion Criteria:\n\n1. Not eligible for chemotherapy\n2. Eligible for stereotactic radiotherapy",{"count":404,"type":21},1500,"5 Years","OBSERVATIONAL","The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.",[68,280,409,33,410,346,411,412,413,414,415,416],"Ganglioglioma","Optic Nerve Glioma","Nerve Sheath Neoplasms","Adenoma","Craniopharyngioma","Hemangiopericytoma","Germinoma","Neurilemmoma","2024-11-25",{"date":419,"type":43},"2024-11-26",{"date":421,"type":43},"2018-01-01",{"date":423,"type":21},"2035-01-01",{"name":425,"class":125},"Maastricht Radiation Oncology",3,{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":126},"100478621","phase-2-sintilimab-one-anti-pd-1-antibody-plus-low-dose-bevacizumab-for-ctdnalevel--relapse-and-clinical-relapse-oligodendroglioma-100478621","NCT05512351","Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Oligodendroglioma","Phase 2 Study to Evaluate the Clinical Efficacy and Safety of Sintilimab Plus Low-dose Bevacizumab in Patients With Oligodendroglioma of Different Relapse Stages","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization obtained from the subject\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by MRI and tumor in situ fluid (TISF) collection\n3. Histologically confirmed diagnosis of oligodendroglioma(WHO III)\n4. Resection surgery done at the study center (Henan Provincial People's Hospital), with an reservoir intraoperatively implanted connecting the surgical cavity and the subscalp for postoperative noninvasive TISF collection\n5. An interval of \\> 28 days and full recovery (i.e., no ongoing safety issues) from surgical resection prior to grouping\n6. Karnofsky performance status (KPS) of 70 or higher\n7. Life expectancy \\> 12 weeks\n\nExclusion Criteria:\n\n1. More than two recurrences of oligodendroglioma\n2. Presence of extracranial metastatic, significant leptomeningeal disease or tumors primarily localized to the brainstem or spinal cord\n3. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n4. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring chronic and systemic immunosuppressive treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects have any other condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days. Inhaled or topical steroids and adrenal replacement doses \\>10mg daily prednisone equivalent are permitted in absence of active autoimmune disease\n5. Previous radiation therapy with anything other than standard radiation therapy (i.e., focally directed radiation) administered as first line therapy\n6. Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to randomization\n7. Previous bevacizumab or other VEGF or anti-angiogenic treatment\n8. Previous treatment with a PD-1, PD-L1 or CTLA-4 targeted therapy\n9. Evidence of \\> Grade 1 CNS hemorrhage on the baseline MRI scan\n10. Inadequately controlled hypertension (defined as systolic blood pressure ≥160 mmHg and \u002For diastolic blood pressure ≥100 mmHg) within 7 days of first study treatment\n11. Prior history of hypertensive crisis, hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome (RPLS)\n12. Prior history of gastrointestinal diverticulitis, perforation, or abscess\n13. Clinically significant (i.e., active) cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment\n14. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment. Any previous venous thromboembolism ≥ NCI CTCAE Grade 3 within 3 months prior to start of study treatment\n15. History of pulmonary hemorrhage\u002Fhemoptysis ≥ grade 2 (defined as ≥ 2.5 mL bright red blood per episode) within 1 month prior to randomization\n16. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n17. Current or recent (within 10 days of study enrollment) use of anticoagulants that, in the opinion of the investigator, would place the subject at significant risk for bleeding. Prophylactic use of anticoagulants is allowed\n18. Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study\n19. Minor surgical procedure (e.g., stereotactic biopsy within 7 days of first study treatment; placement of a vascular access device within 2 days of first study treatment)\n20. History of intracranial abscess within 6 months prior to randomization\n21. History of active gastrointestinal bleeding within 6 months prior to randomization\n22. Serious, non-healing wound, active ulcer, or untreated bone fracture\n23. Subjects unable (due to existent medical condition, e.g., pacemaker or ICD device) or unwilling to have a head contrast enhanced MRI\n24. Positive test for hepatitis B virus surface antigen (HBV sAg) or detectable hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection\n25. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n26. History of severe hypersensitivity reaction to any monoclonal antibody\n27. Patients that require decadron \\> 4 mg\u002F day or equivalent of steroids",{"count":435,"type":21},80,[64],"This is an ongoing Phase 2, open-label, single-center, non-randomized study of sintilimab (one anti-PD-1 antibody same as nivolumab approved in China) plus bevacizumab administered in a low dosage schedule in adult (≥ 18 years) participants with a clinical relapse or circulating tumor DNA (ctDNA)-level relapse of Oligodendroglioma(WHO III).\n\nThis study has three non-comparative study groups. Cohort 1 and Cohort 2 will receive the same study drug sintilimab 200mg and bevacizumab 3mg\u002Fkg every 3 weeks. Cohort 3 will take only standard treatment. A stringent three-step non-randomized process will be used to assign participants to one of the study groups. Neither participants nor doctors but the researcher can choose which group participants are in. No one knows if one study group is better or worse than the other. 80 total participants are expected to participate in this study (30 participants in Cohort 1 and Cohort 2).\n\nGrouping process: After enrollment, under the standard of care, participants will receive regular tumor in situ fluid (fluid within the surgical cavity, TISF) sampling for ctDNA analysis and recceive regular MRI. The researcher will study the TISF ctDNA and imaging dynamics to determine whether the tumor reaches to ctDNA-level (Cohort 1) or clinical relapse (Cohort 2). At the first step, all timely identified as ctDNA-level relapse tumors will be assigned into the Cohort 1 and receive the study drug immediately, those failed to be timely identified will be assigned into the Cohort 2 and receive the study drug after the clinical relapse. At the second step, once Cohort 1 or Cohort 2 reaches the target number, the new participants will be all assigned into the other Cohort. In the third step, if no CTDNA-level or clinical relapse was observed within 60 months after surgery, patients were assigned to Cohort 3 and further analyzed for prognostic biomarkers compared with Cohort 1 and Cohort 2.",[33],"2022-09-25",{"date":441,"type":43},"2022-09-27",{"date":443,"type":21},"2022-12-23",{"date":299,"type":21},{"name":446,"class":125},"Henan Provincial People's Hospital",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":126},"100182422","phase-3-efficacy-of-post-radiation-adjuvant-temozolomide-chemotherapy-in-residue-low-grade-glioma-100182422","NCT01649830","Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma","Inclusion Criteria:\n\n* Age: 18 years to 60 years\n* Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma\n* Karnofsky Performance Score ≥ 60\n* Adequate bone marrow, liver and renal function\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate the study\n* Known hypersensitivity or contraindication to temozolomide\n* Previous irradiation, prior radiosurgery or prior chemotherapy\n* Pregnant or lactating females\n* Malignant tumor other than brain tumor\n* Contraindicated for MRI examination\n* Unable to comply with the follow-up studies of this trial","60 Years",{"count":455,"type":21},290,[24],"Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.",[68,33,459],"Oligodendroastrocytoma",[461,112,462],"low-grade glioma","chemotherapy","2020-05-26",{"date":465,"type":43},"2020-05-28",{"date":467,"type":4},"2012-07",{"date":469,"type":21},"2026-08",{"name":471,"class":125},"Sun Yat-sen University"]