Glioblastoma targeted treatment option maximization by WGS (GLOW);Maximizing treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnostics

Recruiting

Conditions: Glioblstoma
malignant brain tumor grade IV
10029211
10009720

Registration Number: NL-OMON54315

Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 235

Inclusion Criteria

1. Histopathologically confirmed IDH wild type glioblastoma, first recurrence
after standard chemoradiation; suitable for standard-of-care re-resection or
biopsy;
2. Age >= 18 years;
3. Able and willing to give written informed consent;
4. Life expectancy >3 months, allowing adequate follow-up of toxicity
evaluation and antitumor activity;
5. KPS performance status >=70;
6. Deemed eligible for targeted treatment options.

Exclusion Criteria

1. Currently actively treated in another antitumor clinical trial (excluding
DRUP and STELLAR studies);
2. Patients with any other clinically significant medical condition which, in
the opinion of the treating physician, makes it undesirable for the patient to
participate in medication studies or which could jeopardize compliance with
study requirements including, but not limited to ongoing or active infection,
significant uncontrolled hypertension, or severe psychiatric illness/social
situations.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dual primary endpoint is the percentage of patients who receive targeted<br /><br>therapy based on the WGS report and overall survival of the patients</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Tumor and blood collection success rate (target >85% of all patients included)<br /><br>- Number of successful WGS reports (reports for >80% of patients for which<br /><br>tumor material was collected)<br /><br>- Number of targeted treatment options identified (at least one potentially<br /><br>actionable DNA alteration in >75% of patients with a WGS report)<br /><br>- Number of experimental treatments available for GBM patients (relevant<br /><br>(off-label) drugs for at least 50% of the identified indications should be<br /><br>available through a study, including the Drug Rediscovery Protocol (DRUP)<br /><br>- Thirty-two percent of patients starting a targeted treatment in presence of<br /><br>actionable variant (currently 16%)</p><br>