RecruitingNot ApplicableNCT04752280

Glioblastoma Radiotherapy Using IMRT or Proton Beams


Sponsor

University Hospital Heidelberg

Enrollment

326 participants

Start Date

Apr 19, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interventions

RADIATIONProton irradiation

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

RADIATIONPhoton irradiation

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


Locations(3)

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsklinikum Gießen und Marburg

Marburg, Germany

Klinikum Stuttgart

Stuttgart, Germany

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NCT04752280


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