{"entity":{"id":"ef-14","kind":"trial","name":"EF-14","aka":[],"tldr":"The trial that made a wearable electric-field device part of glioblastoma care, extending median survival by about five months.","summary":"EF-14, trial NCT00916409 sponsored by Novocure and reported in 2015, made a wearable electric-field device part of glioblastoma care by extending median survival by about five months when added to maintenance temozolomide. It randomised 695 patients with newly diagnosed glioblastoma after chemoradiation, open-label, to tumour treating fields plus temozolomide or temozolomide alone, met its primary progression-free survival endpoint, improved overall survival and was stopped early for efficacy, with benefit correlating with hours of device use. OnCo links it to tumour treating fields, the Optune device record, temozolomide, Novocure, Roger Stupp and the brain as a bottleneck. The trial is debated for its lack of a sham control and has no independent randomised replication, so whether the effect is real or partly an artefact of design is the open question.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00916409","url":"https://clinicaltrials.gov/study/NCT00916409"}],"tags":[],"related":[],"cancers":["glioblastoma"],"sections":[],"technologies":["ttfields"],"targets":[],"drugs":["optune","temozolomide"],"companies":["novocure"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["roger-stupp"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00916409","phase":"3","setting":"Newly diagnosed glioblastoma after chemoradiation: TTFields + maintenance temozolomide vs temozolomide alone","sponsor":"Novocure","result":"OS 20.9 vs 16.0 months, HR 0.63.","started":"2009-06","yearReported":2015,"enrolled":695,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"TTFields + temozolomide","n":466,"value":6.7},{"name":"Temozolomide","n":229,"value":4}],"hr":0.63,"ci":[0.52,0.76],"p":"<0.001","source":"https://jamanetwork.com/journals/jama/fullarticle/2666504"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"TTFields + temozolomide","value":20.9},{"name":"Temozolomide","value":16}],"hr":0.63,"ci":[0.53,0.76],"source":"https://jamanetwork.com/journals/jama/fullarticle/2666504"}],"replication":"Single pivotal trial without a sham control; no independent randomised replication."},"route":"/trials/ef-14/","neighbours":{"cancer":[{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"technology":[{"id":"ttfields","kind":"technology","name":"Tumour treating fields (TTFields)","route":"/technologies/ttfields/"}],"drug":[{"id":"optune","kind":"drug","name":"Optune / Optune Pax (TTFields)","route":"/drugs/optune/"},{"id":"temozolomide","kind":"drug","name":"Temozolomide","route":"/drugs/temozolomide/"}],"company":[{"id":"novocure","kind":"company","name":"Novocure","route":"/companies/novocure/"}],"person":[{"id":"roger-stupp","kind":"person","name":"Roger Stupp","route":"/people/roger-stupp/"}],"bottleneck":[{"id":"b-brain-delivery","kind":"bottleneck","name":"The brain: barrier and sanctuary","route":"/bottlenecks/b-brain-delivery/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}]}}