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Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

NCT05768087 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-05-09

No results posted yet for this 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.

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

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anouk K Trip, MD PhD · Danish Centre for Particle Therapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-10-31
Completion
2029-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768087 on ClinicalTrials.gov