At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed glioblastoma WHO grade IV
- ✓Indication for radiotherapy or radiochemotherapy
- ✓Informed consent provided
- ✓Age 18 years or older
- ✕Unable to provide informed consent
- ✕Prior radiotherapy to brain or skull base
- ✕Active medical implants without ion radiation authorization
- ✕Contraindication to MRI imaging
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Glioblastoma Radiotherapy Using IMRT or Proton Beams
In Brief
A clinical study evaluating Proton irradiation and Photon irradiation for Glioblastoma. Currently recruiting, targeting 326 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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