RecruitingNot ApplicableNCT04752280

Glioblastoma Radiotherapy Using IMRT or Proton Beams


Sponsor

University Hospital Heidelberg

Enrollment

326 participants

Start Date

Apr 19, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares standard radiation therapy (IMRT) with proton beam therapy for patients with glioblastoma (a type of aggressive brain tumor), to see whether proton therapy offers any advantages in outcomes or side effects. **You may be eligible if...** - You have been confirmed by biopsy to have glioblastoma (WHO grade IV brain tumor) - You require radiation therapy, with or without chemotherapy - You are 18 years or older - You are in reasonably good functional health (Karnofsky score ≥60 or ECOG 0/1) - You are using effective contraception if applicable **You may NOT be eligible if...** - You are unable to give informed consent - You do not meet the health or cancer criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton irradiation

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

RADIATIONPhoton 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

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NCT04752280


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