NCT04752280: GRIPS

Glioblastoma Radiotherapy Using IMRT or Proton Beams

Recruiting now NA Last updated 10 March 2026

What this trial tests

NA trial testing Proton irradiation in Glioblastoma in 326 participants. Currently enrolling.

Timeline

19 April 2021

Primary endpoint
19 September 2030

19 January 2033

Quick facts

Lead sponsor	University Hospital Heidelberg
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	326
Start date	19 April 2021
Primary completion	19 September 2030
Estimated completion	19 January 2033
Sites	3 locations across Germany

Drugs / interventions tested

• Proton irradiation
• Photon irradiation

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

University Hospital Heidelberg

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proton versus photon radiation therapy: A clinical review.
   Chen Z, Dominello MM, Joiner MC, Burmeister JW. · · 2023 · cited 32× · PMID 37064131 · DOI 10.3389/fonc.2023.1133909
2. MDM2/X Inhibitors as Radiosensitizers for Glioblastoma Targeted Therapy.
   Miles X, Vandevoorde C, Hunter A, Bolcaen J. · · 2021 · cited 26× · PMID 34307171 · DOI 10.3389/fonc.2021.703442
3. Factors affecting the radiation response in glioblastoma.
   Aiyappa-Maudsley R, Chalmers AJ, Parsons JL. · · 2022 · cited 17× · PMID 36325371 · DOI 10.1093/noajnl/vdac156
4. 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.
   König L, Jäkel C, von Knebel Doeberitz N, Kieser M, et al · · 2021 · cited 9× · PMID 34930368 · DOI 10.1186/s13014-021-01962-8
5. Mitigating Radiotoxicity in the Central Nervous System: Role of Proton Therapy.
   Winter SF, Vaios EJ, Shih HA, Grassberger C, et al · · 2023 · cited 8× · PMID 37728819 · DOI 10.1007/s11864-023-01131-x
6. Glioblastoma Radiotherapy Using Intensity Modulated Radiotherapy (IMRT) or Proton Radiation - GRIPS Trial (Glioblastoma Radiotherapy via IMRT or Proton BeamS): A Study Protocol for a Multicenter, Prospective, Open-label, Randomized, Two-arm, Phase III Study.
   König L, Jäkel C, Döberitz NvK, Kieser M, et al · · 2021 · DOI 10.21203/rs.3.rs-858113/v1