Clinical trial · Interventional
Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)
(Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Glioblastoma | Glioblastoma, IDH-Wildtype | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Laser Interstitial Thermal Therapy (LITT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control group (biopsy group)
- description
- Standard of care: biopsy + adjuvant treatment
- interventionNames
- Procedure: Biopsy
- type
- EXPERIMENTAL
- label
- Intervention group (LITT group)
- description
- Biopsy + LITT + adjuvant treatment
- interventionNames
- Procedure: Laser Interstitial Thermal Therapy (LITT)
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent, age \>18 years * Suspected glioblastoma * Supratentorial localization * Patient is not amendable for surgical resection as decided by the tumor board * Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures * Karnofsky Performance Status (KPS) \>=70 Exclusion Criteria: * Contra-indication for general anesthesia or MRI * Non-glioblastoma diagnosis on pathology analysis * No final pathology available * Pregnancy * Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires
References
Publications (37)
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- BACKGROUNDStupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. PMID 15758009
- BACKGROUNDWeller M, van den Bent M, Hopkins K, Tonn JC, Stupp R, Falini A, Cohen-Jonathan-Moyal E, Frappaz D, Henriksson R, Balana C, Chinot O, Ram Z, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Malignant Glioma. EANO guideline for the diagnosis and treatment of anaplastic gliomas and glioblastoma. Lancet Oncol. 2014 Aug;15(9):e395-403. doi: 10.1016/S1470-2045(14)70011-7. PMID 25079102
- BACKGROUNDBrown TJ, Brennan MC, Li M, Church EW, Brandmeir NJ, Rakszawski KL, Patel AS, Rizk EB, Suki D, Sawaya R, Glantz M. Association of the Extent of Resection With Survival in Glioblastoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1460-1469. doi: 10.1001/jamaoncol.2016.1373. PMID 27310651
- De Witt Hamer PC, Ho VKY, Zwinderman AH, Ackermans L, Ardon H, Boomstra S, Bouwknegt W, van den Brink WA, Dirven CM, van der Gaag NA, van der Veer O, Idema AJS, Kloet A, Koopmans J, Ter Laan M, Verstegen MJT, Wagemakers M, Robe PAJT; Quality Registry Neuro Surgery glioblastoma working group from the Dutch Society of Neurosurgery. Between-hospital variation in mortality and survival after glioblastoma surgery in the Dutch Quality Registry for Neuro Surgery. J Neurooncol. 2019 Sep;144(2):313-323. doi: 10.1007/s11060-019-03229-5. Epub 2019 Jun 24.