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RECRUITING
NCT04752280
NA

Glioblastoma Radiotherapy Using IMRT or Proton Beams

Sponsor: University Hospital Heidelberg

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

326

Start Date

2021-04-19

Completion Date

2033-01-19

Last Updated

2026-03-10

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Proton irradiation

proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)

RADIATION

Photon irradiation

proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy

Locations (3)

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsklinikum Gießen und Marburg

Marburg, Germany

Klinikum Stuttgart

Stuttgart, Germany