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NCT05768087Not yet recruiting

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 -
University of AarhusClinicalTrials.govradiation
Verified
Study focus
Disease/Condition
Glioblastoma
Drug/Device/Intervention
Escalated proton therapy
Study type
Interventional
Intervention type
radiation
Sponsor & location
Primary sponsor
University of Aarhus
Location
Aarhus, Denmark
Timeline & enrollment
Phase
N/A
Start date
May 01, 2023
End date
May 01, 2029
Enrollment
36 participants
Primary outcome

Adverse Events,Dose Limiting Toxicities

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.

ICD-10 classifications
Malignant neoplasm of brainMalignant neoplasm: Brain, unspecifiedMesotheliomaMalignant neoplasm: Brain stemMalignant neoplasm: Overlapping lesion of brain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05768087
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05768087 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Aarhus and is currently Not yet recruiting. The study focuses on Glioblastoma. Target enrollment is 36 participants.

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