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

Phase 3

Recruiting

• Conditions: brain cancer; glioblastoma; 10029211

• Registration Number: NL-OMON51323
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 238

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are overall survival (OS) and quality-of-life (QoL) using<br /><br>QLQ-C30+BN20 questionnaire. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are disease-specific and progression-free survival (PFS),<br /><br>generic QoL using EQ5D-5L, complication rates, tumor volume response, effects<br /><br>on adjuvant treatment and costs.</p><br>