Glioblastoma Radiotherapy Using IMRT or Proton Beams

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

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

Study 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

Primary outcome measure(s)

• Cumulative rate of toxicity — from start of radiotherapy until progress (max. month 4)
  Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))

Trial sites (3)

More University Hospital Heidelberg trials in Germany

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