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)
NCT Number: NCT04752280
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Universitätsklinikum Heidelberg, Heidelberg, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)
proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy
Time frame: from start of radiotherapy until progress (max. month 4)
Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))
Time frame: 1 year and 2 years
Progression free survival
Time frame: 1 year and 2 years
Overall survival
Time frame: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)
according to CTC AE V5.0
Time frame: 6 weeks after end of therapy (end of therapy up to month 4)
according to CTC AE V5.0
Time frame: 1 year and 2 years
according to EORTC QLQ-C30
Time frame: 1 year and 2 years
according to EORTC QLQ-BN20
Time frame: 1 year and 2 years
according to Hopkins Verbal Learning Test-Revised
Time frame: end of therapy up to month 4
Contact information is provided by the study sponsor or research team.
Klaus Herfarth, Prof. Dr.
CONTACT
+49 6221 56 311584 ext. 34091
Laila König, Prof. Dr.
CONTACT
+49 6221 56 36318 ext. 36318
University Hospital Heidelberg
Other
Acronym: GRIPS
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