NCT05318612Active, not recruitingPhase 3
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 · Last updated 10 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (estimated)
- First submitted
- 23 Mar 2022
- Start date
- 8 Apr 2022
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Glioblastoma
- NCT number
- NCT05318612
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 238
- From 8 Apr 2022 to the primary completion date, 31 Oct 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.