Glioblastoma Radiotherapy Using IMRT or Proton Beams

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.

Interventions

• Proton irradiation · RADIATION

  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 · RADIATION

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
* Indication for radiotherapy / radiochemotherapy
* Informed consent
* KI ≥ 60% or ECOG 0/1
* Age ≥ 18 years
* Sufficient effective contraception

Exclusion Criteria:

* 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
* Simultaneous participation in another clinical trial that could influence the outcome of this study or other study

Sites (3)

• Universitätsklinikum Heidelberg, Heidelberg, Germany · RECRUITING
• Universitätsklinikum Gießen und Marburg, Marburg, Germany · NOT_YET_RECRUITING
• Klinikum Stuttgart, Stuttgart, Germany · NOT_YET_RECRUITING