[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548357":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":290,"collaborators":292,"id":326,"slug":327,"hasResults":328,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":43,"eligibilityCriteria":332,"healthyVolunteers":328,"sex":333,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":43,"studyType":339,"phases":340,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":79,"whyStopped":43,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment arm","EXPERIMENTAL","arm with temozolomide (TMZ) plus lomustine (LOM) treatment.\n\n6 cycles of LOM\u002FTMZ Start day 1 of RT. Cycle length of 42 days. Duration 9 months.",[13,14],"Drug: Temozolomide","Drug: Lomustine",{"label":16,"type":17,"description":18,"interventionNames":19},"standard arm","ACTIVE_COMPARATOR","arm with standard of care treatment with temozolomide only.\n\nOral TMZ 75 mg\u002Fm2 daily during RT and with start day 1 of RT. This is followed by 6 cycles of TMZ with start 4 weeks after the end of RT. Cycle length 28 days. Duration 8,5 months.",[13],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Temozolomide","In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills",[16,9],[27],"TMZ",{"type":22,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"Lomustine",[9],[32],"LOM",[34],{"name":35,"affiliation":36,"role":37},"Annika Malmström, MD, PhD","University Hospital, Linkoeping","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Asgeir S Jakola, MD, PhD","CONTACT","+46313429741",null,"asgeir.jakola@vgregion.se",{"name":46,"role":41,"phone":43,"phoneExt":43,"email":47},"Annika Malmström, MD. PhD","annika.malmstrom@regionostergotland.se",[49,65,77,90,99,113,127,139,151,163,175,189,201,214,226,238,250,258,266,278],{"facility":50,"status":51,"city":52,"state":43,"zip":43,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University Hospital Graz","NOT_YET_RECRUITING","Graz","Austria","AT",{"type":56,"coordinates":57},"Point",[58,59],15.44197,47.06733,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":43,"phoneExt":43,"email":64},"PI Tadeja Urbanic Purkart","tadeja.urbanic-purkart@medunigraz.at",{"facility":66,"status":51,"city":67,"state":43,"zip":43,"country":53,"countryCode":54,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Medizinische Universität Innsbruck","Innsbruck",{"type":56,"coordinates":69},[70,71],11.39454,47.26266,{"lat":71,"lon":70},[74],{"name":75,"role":41,"phone":43,"phoneExt":43,"email":76},"PI Martha Nowosielski","martha.nowosielski@i-med.ac.at",{"facility":78,"status":79,"city":80,"state":43,"zip":43,"country":53,"countryCode":54,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Kepler University Hospital","RECRUITING","Linz",{"type":56,"coordinates":82},[83,84],14.28611,48.30639,{"lat":84,"lon":83},[87],{"name":88,"role":41,"phone":43,"phoneExt":43,"email":89},"PI Isolde Hoellmueller","isolde.hoellmueller@kepleruniklinikum.at",{"facility":91,"status":92,"city":93,"state":43,"zip":43,"country":53,"countryCode":54,"cosmosGeoPoint":94,"geoPoint":98,"contacts":43},"University Hospital St. Pölten","ENROLLING_BY_INVITATION","Sankt Pölten",{"type":56,"coordinates":95},[96,97],15.63725,48.20762,{"lat":97,"lon":96},{"facility":100,"status":79,"city":101,"state":43,"zip":43,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Aarhus University Hospital","Aarhus","Denmark","DK",{"type":56,"coordinates":105},[106,107],10.21076,56.15674,{"lat":107,"lon":106},[110],{"name":111,"role":41,"phone":43,"phoneExt":43,"email":112},"PI Slavka Lukacova","Slavka.lukacova@auh.rm.dk",{"facility":114,"status":79,"city":115,"state":43,"zip":43,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Haukeland University Hospital","Bergen","Norway","NO",{"type":56,"coordinates":119},[120,121],5.32415,60.39299,{"lat":121,"lon":120},[124],{"name":125,"role":41,"phone":43,"phoneExt":43,"email":126},"PI Jorunn Brekke","jorunn.brekke@helse-bergen.no",{"facility":128,"status":79,"city":129,"state":43,"zip":43,"country":116,"countryCode":117,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Sorlandet Sykehus","Kristiansand",{"type":56,"coordinates":131},[132,133],7.9956,58.14671,{"lat":133,"lon":132},[136],{"name":137,"role":41,"phone":43,"phoneExt":43,"email":138},"PI Rene van Heilvort","Rene.helvoirt@sshf.no",{"facility":140,"status":79,"city":141,"state":43,"zip":43,"country":116,"countryCode":117,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Oslo University Hospital","Oslo",{"type":56,"coordinates":143},[144,145],10.74609,59.91273,{"lat":145,"lon":144},[148],{"name":149,"role":41,"phone":43,"phoneExt":43,"email":150},"PI Petter Brandal","pebra@ous-hf.no",{"facility":152,"status":51,"city":153,"state":43,"zip":43,"country":116,"countryCode":117,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Stavanger University Hospital","Stavanger",{"type":56,"coordinates":155},[156,157],5.73332,58.97005,{"lat":157,"lon":156},[160],{"name":161,"role":41,"phone":43,"phoneExt":43,"email":162},"PI Line Sagerup Bjorland","line.bjorland@sus.no",{"facility":164,"status":51,"city":165,"state":43,"zip":43,"country":116,"countryCode":117,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"St Olavs Hospital","Trondheim",{"type":56,"coordinates":167},[168,169],10.39506,63.43049,{"lat":169,"lon":168},[172],{"name":173,"role":41,"phone":43,"phoneExt":43,"email":174},"PI Tora S. Solheim","Tora.Skeidsvoll.Solheim@stolav.no",{"facility":176,"status":79,"city":177,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Gävle Hospital","Gävle","Sweden","SE",{"type":56,"coordinates":181},[182,183],17.14174,60.67452,{"lat":183,"lon":182},[186],{"name":187,"role":41,"phone":43,"phoneExt":43,"email":188},"PI Kyriaki Christodoulou","kyriaki.christodoulou@regiongavleborg.se",{"facility":190,"status":79,"city":191,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Sahlgrenska University Hospital","Gothenburg",{"type":56,"coordinates":193},[194,195],11.96679,57.70716,{"lat":195,"lon":194},[198],{"name":199,"role":41,"phone":43,"phoneExt":43,"email":200},"PI Erik Fernström","erik.fernstrom@vgregion.se",{"facility":202,"status":79,"city":203,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Ryhov County Hospital","Jönköping",{"type":56,"coordinates":205},[206,207],14.15618,57.78145,{"lat":207,"lon":206},[210,212],{"name":211,"role":41,"phone":43,"phoneExt":43,"email":43},"PI Michael Strandéus",{"name":43,"role":41,"phone":43,"phoneExt":43,"email":213},"michael.strandeus@rjl.se",{"facility":215,"status":79,"city":216,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Kalmar Country Hospital","Kalmar",{"type":56,"coordinates":218},[219,220],16.36163,56.66157,{"lat":220,"lon":219},[223],{"name":224,"role":41,"phone":43,"phoneExt":43,"email":225},"PI Nathalie Skarin","nathalie.skarin@regionkalmar.se",{"facility":227,"status":51,"city":228,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Skåne University Hospital","Lund",{"type":56,"coordinates":230},[231,232],13.19321,55.70584,{"lat":232,"lon":231},[235],{"name":236,"role":41,"phone":43,"phoneExt":43,"email":237},"PI Sara Kinhult","Sara.Kinhult@skane.se",{"facility":239,"status":79,"city":240,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Örebro University Hospital","Örebro",{"type":56,"coordinates":242},[243,244],15.2066,59.27412,{"lat":244,"lon":243},[247],{"name":248,"role":41,"phone":43,"phoneExt":43,"email":249},"PI David Löfgren","david.lofgren@regionorebrolan.se",{"facility":251,"status":92,"city":252,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":253,"geoPoint":257,"contacts":43},"Karolinska Institutet","Stockholm",{"type":56,"coordinates":254},[255,256],18.06871,59.32938,{"lat":256,"lon":255},{"facility":259,"status":92,"city":260,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":261,"geoPoint":265,"contacts":43},"Sundsvall Hospital","Sundsvall",{"type":56,"coordinates":262},[263,264],17.3063,62.39129,{"lat":264,"lon":263},{"facility":267,"status":79,"city":268,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Norrlands Universitetssjukhus, Umea, Sweden","Umeå",{"type":56,"coordinates":270},[271,272],20.25972,63.82842,{"lat":272,"lon":271},[275],{"name":276,"role":41,"phone":43,"phoneExt":43,"email":277},"PI Maria Sandström","maria.sandstrom@umu.se",{"facility":279,"status":79,"city":280,"state":43,"zip":43,"country":178,"countryCode":179,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Uppsala University Hospital","Uppsala",{"type":56,"coordinates":282},[283,284],17.63889,59.85882,{"lat":284,"lon":283},[287],{"name":288,"role":41,"phone":43,"phoneExt":43,"email":289},"PI Pernilla Roswall","pernilla.roswall@regionuppsala.se",{"type":291,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[293,296,297,298,299,300,302,303,305,306,308,310,311,313,315,316,318,321,323,324],{"name":294,"class":295},"Skane University Hospital","OTHER",{"name":176,"class":295},{"name":251,"class":295},{"name":190,"class":295},{"name":202,"class":295},{"name":301,"class":295},"Kalmar County Hospital",{"name":140,"class":295},{"name":304,"class":295},"St. Olavs Hospital",{"name":114,"class":295},{"name":307,"class":6},"Sorlandet Hospital HF",{"name":309,"class":6},"Helse Stavanger HF",{"name":100,"class":295},{"name":312,"class":295},"Region Örebro County",{"name":314,"class":295},"University Hospital, Umeå",{"name":279,"class":295},{"name":317,"class":295},"Universitäts-Frauenklinik Graz",{"name":319,"class":320},"University Hospital of Sankt Pölten","UNKNOWN",{"name":322,"class":320},"Sundsvalls Hospital",{"name":78,"class":295},{"name":325,"class":320},"medizinische universität innsbruck, Austria","100548357","phase-3-lomustine-in-addition-to-standard-of-care-in-patients-with-mgmt-methylated-glioblastoma-100548357",false,"NCT06419946","Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma","Phase III Trial of Temozolomide\u002FLomustine (TMZ\u002FLOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +\u002F- Tumor Treating Fields (Optune)","Inclusion Criteria:\n\n* Newly diagnosed glioblastoma\u002Fgliosarcoma, IDH wild type\n* Methylated MGMT promoter\n* World Health Organization performance status 0-2\n* Age 18-70\n\nExclusion Criteria:\n\n* Previous malignancy within 3 y or malignancy treated non-curatively\n* Previous chemotherapy or radiotherapy involving the head\n* Off-protocol tumor-specific treatment\n* Serious comorbidity","ALL","18 Years","70 Years",{"count":337,"type":338},200,"ESTIMATED","INTERVENTIONAL",[341],"PHASE3","Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile.\n\nHypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ.\n\nTreatment Plans: The study will randomly assign participants to two groups:\n\n* Control Group: Standard treatment with TMZ during and after radiation therapy.\n* Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy.\n\nOutcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes.",[344,345],"Glioblastoma, IDH-wildtype","MGMT-Methylated Glioblastoma",[347,348,349,350,351],"precision medicine","temozolomide","lomustine","CCNU","survival","2026-04-07",{"date":354,"type":355},"2026-04-13","ACTUAL",{"date":357,"type":355},"2025-02-01",{"date":359,"type":338},"2033-12-15",{"name":5,"class":6},20]