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Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Gießen und Marburg
Marburg, Germany
Klinikum Stuttgart
Stuttgart, Germany
Start Date
April 19, 2021
Primary Completion Date
September 19, 2030
Completion Date
January 19, 2033
Last Updated
March 10, 2026
326
ESTIMATED participants
Proton irradiation
RADIATION
Photon irradiation
RADIATION
Lead Sponsor
University Hospital Heidelberg
NCT06860594
NCT00083512
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05839379