[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"astrocytoma-grade-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:astrocytoma-grade-iii":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,87,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100498096","phase-1-a-study-of-debio-0123-in-combination-with-temozolomide-in-adult-participants-with-recurrent-or-progressive-glioblastoma-and-of-debio-0123-in-combination-with-temozolomide-and-radiotherapy-in-adult-participants-with-newly-diagnosed-glioblastoma-100498096",false,"NCT05765812","A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","A Phase 1\u002F2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","Screening Inclusion Criteria for Phase 1 and Phase 2:\n\n* Signed written informed consent approved before undertaking any study-specific procedures.\n* Age ≥18 years of age.\n* Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.\n* Adequate bone marrow, hepatic, and renal function.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Willing to practice highly effective methods of contraception.\n* Life expectancy of at least 3 months in the best judgment of the Investigator.\n* Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n\nAdditional specific inclusion criteria for Phase 1 and Phase 2:\n\n• A maximum of 1 \\[for Phase 1 (Dose Expansion) and phase 2\\] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).\n\nNote: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers \\[GLIADEL®\\]) for first recurrence is allowed.\n\n* Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.\n* KPS ≥60.\n\nAdditional specific inclusion criteria for Phase 1 Arm A:\n\n* Participants must have one of the following histopathologically proven diagnoses (WHO 2021):\n* GBM Isocitrate dehydrogenase (IDH)-wildtype Grade 4 which may include secondary GBMs (i.e., those that progress from low-grade gliomas).\n* Astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific inclusion criteria for Phase 1 Arm B and C:\n\n* Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior treatment included surgery only.\n* KPS ≥70.\n\nAdditional specific inclusion criteria for Phase 1 dose expansion and Phase 2:\n\n• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021\n\nAdditional specific exclusion criteria for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific exclusion criteria for Phase 1 and Phase 2\n\n* Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.\n* Any anticancer treatment, monoclonal antibodies\u002Fbiologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.\n* Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ.\n* Prior exposure to any WEE1 inhibitor.\n* History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell\u002Fsquamous cell skin cancer) that have been treated with curative intent.\n* Left ventricular ejection fraction (LVEF) below 55%.\n\nAdditional specific exclusion criteria for Phase 1 Arm B and C:\n\n* Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.\n* Prior therapy that would result in an overlap of the radiation fields.\n\nAdditional specific exclusion criteria for Phase 1 dose expansion and Phase 2\n\n• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.\n\n\\[Note: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.\\]","ALL","18 Years",{"count":19,"type":20},116,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.\n\nThe primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development.\n\nThe Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.",[27,28],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Astrocytoma, Grade III",[30,31,32],"WEE1 inhibitor","Glioblastoma, IDH-wildtype, Grade 4, World Health Organization (WHO) 2021","Astrocytoma, IDH-mutant, Grade 3, WHO 2021","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-12","ACTUAL",{"date":39,"type":37},"2023-05-15",{"date":41,"type":20},"2028-09",{"name":43,"class":44},"Debiopharm International SA","INDUSTRY",16,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"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":56,"type":20},60,[24],"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.",[60,61,28,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"High Grade Glioma","Astrocytoma","Astrocytoma, Grade IV","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","Oligodendroglioma","2026-06-10",{"date":36,"type":37},{"date":81,"type":37},"2025-02-01",{"date":83,"type":20},"2035-06",{"name":85,"class":44},"Rigel Pharmaceuticals",20,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100331501","phase-1-hsv-tk--valacyclovir--sbrt--chemotherapy-for-recurrent-gbm-100331501","NCT03596086","HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM","Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination With Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme","Inclusion Criteria:\n\n* All patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem involvement. Multifocal disease does not exist if enhancing areas are connected by abnormal T2 FLAIR on the MRI scan.\n* Radiographic evidence of recurrence\u002Fprogression by iRANO criteria\n* ≥ 3 weeks since any major surgery, completion of RT, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).\n* Life expectancy ≥ 12 weeks.\n* Patient can receive second treatment of HSV-tk after 6 months\n* Patients should have the following characteristics: recurrent glioblastoma or AA demonstrated by biopsy or imaging study, ECOG performance status of 0-1, has had prior surgery and radiotherapy \u002Fchemotherapy for the glioblastoma.\n* Patients with leptomeningeal disease may be considered for enrollment into the study.\n* No evidence of other active malignancy (except squamous or basal cell skin cancers).\n* Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his\u002Fher designee) with the aid of written information.\n* Willing to provide biopsies as required by the study.\n* WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating.\n* WOCBP and men must practice an effective method of birth control\n* Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol:\n\n  * serum creatinine \\\u003C 1.5 mg\u002FdL\n  * T. bilirubin \\\u003C 2.5 mg\u002FdL, ALT, AST, GGT and AP \\\u003C 2 x normal\n  * Platelet count. \\> 100,000\u002Fml , ANC\\> 1500\u002Fml , Hgb\\> 10 gm\u002FdL\n  * Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)\n* Non English speaking patients can participate in this study\n\nExclusion Criteria\n\n* Prior treatment with immunomodulatory therapy, immunotherapy, and\u002For gene vector therapy in the past 3 months.\n* Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start.\n* Evidence of multifocal disease, brainstem involvement\n* Patients on immunosuppressive drugs (other than steroids for brain edema).\n* In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.\n* In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled.\n* Liver disease, such as cirrhosis or active\u002Fchronic hepatitis B or C.\n* History of or current alcohol misuse\u002Fabuse within the past 12 months.\n* Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector-HSV-tk, Valacyclovir).\n* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).\n* No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 5 years.\n* Pregnant or breastfeeding women or women\u002Fmen able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment.\n* Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.\n* Patients \\\u003C 18 years of age\n* Unwilling or unable to comply with the study protocol.\n* The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging.\n* The presence of active untreated cellulitis or untreated wound infections. Treated and resolving cellulitis and infections are not an exclusion criteria.\n* Active IV drug abuse or severe opioid abuse",{"count":95,"type":20},62,[23,24],"Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.",[99,28],"Glioblastoma Multiforme",[101,102,61],"GBM","glioblastoma","2026-03-25",{"date":105,"type":37},"2026-03-30",{"date":107,"type":37},"2017-12-11",{"date":109,"type":20},"2026-12-30",{"name":111,"class":112},"David Baskin MD","OTHER",1,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206","NCT06118723","The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","SUPRAMAX","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Multifocal contrast enhancing lesions\n3. Medical reasons precluding MRI (e.g. pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin","90 Years",{"count":124,"type":20},784,"OBSERVATIONAL","A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[128,129,130,131,132,62,28,133,134,135,136,137],"Glioblastoma","High-grade Glioma","Glioblastoma, IDH-wildtype","Glioblastoma, IDH-mutant","Glioblastoma Multiforme, Adult","Astrocytoma, Malignant","Brain Neoplasms","Brain Neoplasm, Primary","Brain Neoplasms, Adult","Brain Neoplasm, Malignant",[128,139,140,141,142,143,144,145],"Supramaximal resection","FLAIRectomy","Non-contrast enhancement","Neurological morbidity","Quality of life","Overall survival","Progression-free survival","2024-02-20",{"date":148,"type":37},"2024-02-22",{"date":150,"type":37},"2022-01-01",{"date":152,"type":20},"2028-01-01",{"name":154,"class":112},"Jasper Gerritsen",8]