RecruitingNot ApplicableNCT05768087

Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

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

Sponsor

University of Aarhus

Enrollment

36 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

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

Min Age: 18 Years

Inclusion Criteria9

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.