About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
Indication for radiotherapy / radiochemotherapy
Informed consent
KI ≥ 60% or ECOG 0/1
Disqualifiers
Patient is not able to consent
Previous radiotherapy in the brain or skull base
Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
Contraindication to MRI imaging
Trial design
Parallel
Treatments tested in this trial
Proton irradiation
Radiationproton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)
Photon irradiation
Radiationproton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy
Treatment groups
Trial outcomes
Primary outcomes
Cumulative rate of toxicity
Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))
Secondary outcomes
Progression free survival
Progression free survival
Overall survival
Overall survival
Acute Toxicity
according to CTC AE V5.0
Late Toxicity
according to CTC AE V5.0
Sponsors and contacts
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