Actively Recruiting
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
Led by University of Aarhus · Updated on 2024-05-09
36
Participants Needed
2
Research Sites
263 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
D
Danish Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this phase 1 dose finding study is to to assess the clinical tolerability and safety of escalated dose proton therapy in glioblastoma patients treated with multimodality treatment, according to treatment volume. The main questions it aims to answer are: * what is the maximum tolerated proton dose in glioblastoma patients? * is the maximum tolerated proton dose in glioblastoma patients dependent on treatment volume? * what is the recommended phase 2 proton dose in glioblastoma patients? Patients will be asked to undergo radiotherapy to step-wise escalated doses using proton therapy as part of their multimodality treatment. Patients will be monitored closely for treatment effects.
CONDITIONS
Official Title
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, contrast-enhancing glioblastoma, IDH wild type (WHO 2021 classification)
- Maximal safe surgical resection performed; any extent of resection including biopsy only allowed
- Patient eligible for 60 Gy chemoradiotherapy based on target volume and location
- Minimum distance of 5 mm between tumor and critical organs on MRI
- Age 18 years or older
- Karnofsky Performance Status of 70 or higher
- Adequate blood counts as determined by treating physician
- No contraindications for MRI or Gadolinium contrast
- Written informed consent provided according to Good Clinical Practice and regulations
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital, Dept. of Oncology
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
2
Danish Centre for Particle Therapy
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
B
Birgit K Bach
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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