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New treatment option for Glioblastoma
Official title Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
ClinicalTrials.gov ID: NCT05768087
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (main):
- Newly diagnosed, contrast-enhancing GBM, IDHwt (WHO 2021 classification).
- Maximal safe surgical resection is required; any extent of surgical resection is allowed (including biopsy-only).
- Patient with target volume and location eligible for 60 Gy chemoradiotherapy.
- Minimum distance between GTV and critical OAR (brainstem, chiasm, optic nerves and tracts in case of serviceable vision) of 5 mm on MRI-scan.
You likely can't join if
- All eligibility criteria are formulated as inclusion criteria.
See the full eligibility criteria
- (main):
- Newly diagnosed, contrast-enhancing GBM, IDHwt (WHO 2021 classification).
- Maximal safe surgical resection is required; any extent of surgical resection is allowed (including biopsy-only).
- Patient with target volume and location eligible for 60 Gy chemoradiotherapy.
- Minimum distance between GTV and critical OAR (brainstem, chiasm, optic nerves and tracts in case of serviceable vision) of 5 mm on MRI-scan.
- Age ≥ 18 years.
- Karnofsky Performance Status grade of ≥ 70.
- Adequate blood counts as assessed by treating physician.
- Absence of any contraindication to undergo MRI and/or to receive Gadolinium contrast agent.
- Before patient registration, written informed consent must be given according to Good Clinical Practice, and national/local regulations.
- All eligibility criteria are formulated as inclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Central Jutland, Denmark
- Aarhus, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Central Jutland, Denmark; Aarhus, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.