Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

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.

Interventions

• Escalated proton therapy · RADIATION

  According to allocated dose level: level 1-8, 69-90 Gy in 30 fractions of 2.3-3.0 Gy, to a subvolume of the radiation target

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (2)

• Aarhus University Hospital, Dept. of Oncology, Aarhus, Central Jutland, Denmark · RECRUITING
• Danish Centre for Particle Therapy, Aarhus, Denmark · RECRUITING