Clinical Trial

Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)

Study acronym: EMITT
Active, Not Recruiting Phase 3
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Record status
This record was last updated April 10, 2024 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70. The current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months). The primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-04-01; most recent amendment 2024-04-09.
Status change: Recruiting → Active, Not Recruiting 2024-04-09
Status change: Not Yet Recruiting → Recruiting 2022-04-13
Trial Details
NCT Number NCT05318612
Lead Sponsor Radboud University Medical Center
Collaborators: Dutch National Health Care Institute, ZonMw: The Netherlands Organisation for Health Research and Development, UMC Utrecht
Conditions Primary Glioblastoma
Enrollment 238 participants
Start Date 2022-04-08
Primary Completion 2025-10-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2024-04-10