MR-guided LITT therapy in patients with primary irresectable glioblastoma: a multicenter randomized controlled trial

MR-guided LITT therapy in patients with primary irresectable glioblastoma: a multicenter randomized controlled trial - EMITT trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51323

Enrollment

238

Registered

2022-03-21

Start date

2022-04-19

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain cancer glioblastoma

Interventions

Patients will be randomized to receive either (i) biopsy and LITT, followed by standard CRT or (ii) biopsy alone, followed by standard CRT.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Informed consent, age >18-year-old - Supratentorial localization - Safe trajectory/trajectories possible for ablation of at least 70% of the tumour, avoiding eloquent structures. - Karnofsky Performance Status (KPS) >= 70

Exclusion criteria

Exclusion criteria: - Contra-indication for general anaesthesia or MRI - Non-glioblastoma diagnosis on pathology analysis - No final pathology diagnosis available - Pregnancy

Design outcomes

Primary

Measure	Time frame
The primary endpoints are overall survival (OS) and quality-of-life (QoL) using QLQ-C30+BN20 questionnaire.	—

Secondary

Measure	Time frame
Secondary endpoints are disease-specific and progression-free survival (PFS), generic QoL using EQ5D-5L, complication rates, tumor volume response, effects on adjuvant treatment and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)