Glioblastoma, Optimizing Logistics and Dose (GOLD).

Phase 3

Recruiting

• Conditions: brain tumor; glioblastoma; 10029211

• Registration Number: NL-OMON52680
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 474

Inclusion Criteria

• Histological diagnosis of GBM with any MGMT-promotor methylation status and
IDH1 mutation
status by multidisciplinary neuro-oncology tumor board.
• Age >= 18 years.
• KPS >=70.
• Surgical biopsy or resection performed.
• Decision of chemoradiation following the Stupp-protocol by multidisciplinary
neuro-oncology
tumour board.

Exclusion Criteria

• Participation in a competing trial.
• Prior overlapping intracranial radiotherapy.
• Known carcinoma < 3 years ago (excluding Carcinoma in situ of the cervix,
basal cell
carcinoma, squamous cell carcinoma of the skin) requiring immediate
treatment interfering with
study therapy and with worse prognosis than glioblastoma.
• Maximum diameter > 6cm (~ reflecting a spherical tumor volume of 125 cc).
• Unwilling or unable to undergo MRI scans.
• Contra-indication for gadolinium contrast.
• Women with childbearing potential without adequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is overall survival. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary endpoints are HRQoL (through questionnaires), cost-effectiveness,<br /><br>progression-free survival, both clinical and radiological toxicity and edema<br /><br>treatment</p><br>