CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 326 target
Drug / intervention
Proton irradiation +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 5
  • Histologically confirmed glioblastoma WHO grade IV
  • Indication for radiotherapy or radiochemotherapy
  • Informed consent provided
  • Age 18 years or older
Key exclusion· 5
  • 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.

Search/NCT04752280
NCT04752280N/ARecruitingOn Track
Long Recruiting

Glioblastoma Radiotherapy Using IMRT or Proton Beams

University Hospital Heidelberg·interventional·Posted Feb 12, 2021·Updated May 27, 2026

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesGermany
Collaborators--

Timeline

N/ARecruiting
2021202220232024202520262027202820292030203120322033
First PostedFeb 12, 2021
Enrollment StartApr 19, 2021
Primary CompletionSep 19, 2030
Study CompletionJan 19, 2033
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 5.4 years agoPrimary completion in 4.2 years

Interventions

Proton irradiationradiation

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

Photon irradiationradiation

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