Clinical trial · Interventional
Glioblastoma Radiotherapy Using IMRT or Proton Beams
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon irradiation | Radiation | — | UNRESOLVED |
| Proton irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Proton irradiation
- description
- Irradiation applied with protons
- interventionNames
- Radiation: Proton irradiation
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Photon IMRT
- description
- Photon irradiation applied as intensity-modulated radiotherapy
- interventionNames
- Radiation: Photon irradiation
Primary outcomes (1)
- measure
- Cumulative rate of toxicity
- timeFrame
- from start of radiotherapy until progress (max. month 4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKonig L, Jakel C, von Knebel Doeberitz N, Kieser M, Eberle F, Munter M, Debus J, Herfarth K. Glioblastoma radiotherapy using Intensity modulated Radiotherapy (IMRT) or proton Radiotherapy-GRIPS Trial (Glioblastoma Radiotherapy via IMRT or Proton BeamS): a study protocol for a multicenter, prospective, open-label, randomized, two-arm, phase III study. Radiat Oncol. 2021 Dec 20;16(1):240. doi: 10.1186/s13014-021-01962-8. PMID 34930368