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ACTIVE NOT RECRUITING
NCT05318612
PHASE3

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

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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.

Official title: (Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2022-04-08

Completion Date

2027-10-31

Last Updated

2024-04-10

Healthy Volunteers

No

Interventions

PROCEDURE

Laser Interstitial Thermal Therapy (LITT)

LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.

PROCEDURE

Biopsy

A sample of tissue from the tumor is obtained to confirm the diagnosis.

Locations (7)

Amsterdam Medical Center

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands