NCT05768087 Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
| NCT ID | NCT05768087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-04-15 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * All eligibility criteria are formulated as inclusion criteria.
Contact & Investigator
Anouk K Trip, MD PhD
PRINCIPAL INVESTIGATOR
Danish Centre for Particle Therapy
Frequently Asked Questions
Who can join the NCT05768087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05768087 currently recruiting?
Yes, NCT05768087 is actively recruiting participants. Contact the research team at dcpt_kfe@rm.dk for enrollment information.
Where is the NCT05768087 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Aarhus, Denmark.
Who is sponsoring the NCT05768087 clinical trial?
NCT05768087 is sponsored by University of Aarhus. The principal investigator is Anouk K Trip, MD PhD at Danish Centre for Particle Therapy. The trial plans to enroll 36 participants.
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