Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

NCT05768087 · tracked via the Priya Life Science Denmark tracker

Sponsor

University of Aarhus

Phase

Not applicable

Started

2024-04-15

Last updated

2024-05-09

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Escalated proton therapy

Escalated proton therapy: 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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Adverse Events — up til 2 years after the end of proton therapy
CTCAE version 5.0
Dose Limiting Toxicities — up til 6 months after the start of proton therapy
CTCAE version 5.0

Trial sites (2)

Facility	City	Region	Status
Aarhus University Hospital, Dept. of Oncology	Aarhus	Central Jutland	Recruiting
Danish Centre for Particle Therapy	Aarhus	Denmark	Recruiting

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Other trials for the same condition

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM Recruiting

Senicapoc and Perampanel for Newly Diagnosed Glioblastoma Recruiting

Supramarginal Resection in Glioblastoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05768087 on ClinicalTrials.gov ↗ ← All trials in Denmark