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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitätsklinikum Gießen und Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Not yet recruiting |
| Klinikum Stuttgart Coordinator of this site? Confirm its status | Stuttgart | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.