Glioblastoma Targeted Treatment Option Maximization by WGS

NCT05186064 | Recruiting DMC

• 1 other identifier: NL79220.058.21 / N21.115
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In Dutch centers performing neurosurgery on and/or treating GBM, all recurrent GBM patients are discussed in local tumor boards and this setup will be used to effectively identify possible GLOW study candidates. 160 patients that will undergo re-resection in the GLOW study will be presented with WGS results leading to added treatment options.

Conditions

Glioblastoma

Keywords

first recurrence; whole genome sequencing

Outcome Measures

Primary Outcomes (1)

• overall survival

  3 years

Secondary Outcomes (2)

• number targeted treatment options identified

  2 years

• percent of patients starting a targeted treatment in presence of actionable variant

  2 years

Study Arms (1)

whole genome sequencing after standard of care resection at first relapse

EXPERIMENTAL

Diagnostic Test: whole genome sequencing

Interventions

whole genome sequencing DIAGNOSTIC_TEST

whole genome sequencing will be performed on tumor material after re-resection per standard of care

whole genome sequencing after standard of care resection at first relapse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed IDH wild type glioblastoma, first recurrence after standard chemoradiation; suitable for standard-of-care re-resection;
• Age ≥ 18 years;
• Able and willing to give written informed consent;
• Life expectancy \>3 months, allowing adequate follow-up of toxicity evaluation and antitumor activity;
• KPS performance status ≥70.

You may not qualify if:

• Currently actively treated in another antitumor clinical trial (excluding DRUP and STELLAR studies);
• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Amsterdam University Medical Center: collaborator
• The Netherlands Cancer Institute: collaborator
• The Elisabeth-TweeSteden Hospital: collaborator
• Erasmus Medical Center: collaborator
• Medical Center Haaglanden: collaborator
• Isala: collaborator
• Leiden University Medical Center: collaborator
• Maastricht University Medical Center: collaborator
• Medisch Spectrum Twente: collaborator
• Radboud University Medical Center: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Haaglanden Medisch Centrum

The Hague, Netherlands

RECRUITING

Related Publications (1)

• van Opijnen MP, Broekman MLD, de Vos FYF, Cuppen E, van der Hoeven JJM, van Linde ME, Compter A, Beerepoot LV, van den Bent MJ, Vos MJ, Fiebrich HB, Koekkoek JAF, Hoeben A, Kho KH, Driessen CML, Jeltema HR, Robe PAJT, Maas SLN. Study protocol of the GLOW study: maximising treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnostics-a prospective multicenter cohort study. BMC Med Genomics. 2022 Nov 4;15(1):233. doi: 10.1186/s12920-022-01343-4.

  PMID: 36333718 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Mark Y van Opijnen

CONTACT

0031-88-9797900; m.van.opijnen@haaglandenmc.nl

Marike Broekman

CONTACT

m.broekman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical oncologist

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: July 25, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)