Escalated dose proton therapy for glioblastoma patients

Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients - A Phase 1 Proton Dose Finding Trial -

This study is testing higher doses of proton therapy for patients with glioblastoma to find out the safest amount they can tolerate while receiving other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aarhus (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Aarhus, Central Jutland and 1 other locations)
• Trial ID: NCT05768087 on ClinicalTrials.gov

What this trial studies

This phase 1 trial aims to determine the maximum tolerated dose of escalated proton therapy in patients with glioblastoma undergoing multimodality treatment. Patients will receive proton therapy with increasing doses while being closely monitored for safety and tolerability. The study will categorize patients based on the volume of their radiation target and utilize a continuous reassessment method to identify the maximum tolerated dose. The trial will conclude once the maximum tolerated dose is established, followed by an expansion cohort for further evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, contrast-enhancing glioblastoma eligible for surgical resection.

Not a fit: Patients with contraindications to MRI or Gadolinium contrast, or those not meeting the inclusion criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment efficacy and safety for glioblastoma patients.

How similar studies have performed: While the use of proton therapy is established, this specific escalated dose approach in glioblastoma is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Aarhus, Central Jutland and 1 other locations

• Aarhus University Hospital, Dept. of Oncology — Aarhus, Central Jutland, Denmark (Recruiting)
• Danish Centre for Particle Therapy — Aarhus, Denmark (Recruiting)

Study contacts

• Principal investigator: Anouk K Trip, MD PhD — Danish Centre for Particle Therapy
• Study coordinator: Birgit K Bach

Conditions Glioblastoma