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RECRUITING
NCT05768087
NA

Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-04-15

Completion Date

2029-05

Last Updated

2024-05-09

Healthy Volunteers

No

Conditions

Interventions

RADIATION

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

Locations (2)

Aarhus University Hospital, Dept. of Oncology

Aarhus, Central Jutland, Denmark

Danish Centre for Particle Therapy

Aarhus, Denmark