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NCT04752280Recruiting

Glioblastoma Radiotherapy Using IMRT or Proton Beams

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
326 (estimated)
First submitted
9 Feb 2021
Start date
19 Apr 2021
Primary completion date
19 Sept 2030
Lead sponsor
University Hospital Heidelberg
Diseases
Glioblastoma
NCT number
NCT04752280

What you commit to

  • Study type: Interventional
  • Planned participants: 326
  • From 19 Apr 2021 to the primary completion date, 19 Sept 2030
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous radiotherapy in the brain or skull base

Other illness

  • Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)

Other

  • Patient is not able to consent
  • Contraindication to MRI imaging
  • Simultaneous participation in another clinical trial that could influence the outcome of this study or other study

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyRecruiting
Universitätsklinikum Gießen und Marburg
Coordinator of this site? Confirm its status
MarburgGermanyNot yet recruiting
Klinikum Stuttgart
Coordinator of this site? Confirm its status
StuttgartGermanyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.