NCT04752280

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
81mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2021Jan 2033

First Submitted

Initial submission to the registry

February 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2030

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2033

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

9.4 years

First QC Date

February 9, 2021

Last Update Submit

March 6, 2026

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • Cumulative rate of toxicity

    Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))

    from start of radiotherapy until progress (max. month 4)

Secondary Outcomes (8)

  • Progression free survival

    1 year and 2 years

  • Overall survival

    1 year and 2 years

  • Acute Toxicity

    start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)

  • Late Toxicity

    6 weeks after end of therapy (end of therapy up to month 4)

  • Quality of life according to EORTC QLQ-C30

    1 year and 2 years

  • +3 more secondary outcomes

Study Arms (2)

Arm A: Proton irradiation

EXPERIMENTAL

Irradiation applied with protons

Radiation: Proton irradiation

Arm B: Photon IMRT

ACTIVE COMPARATOR

Photon irradiation applied as intensity-modulated radiotherapy

Radiation: Photon irradiation

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)

Arm A: Proton irradiation
Photon irradiationRADIATION

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

Arm B: Photon IMRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitätsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg

Marburg, Germany

NOT YET RECRUITING

Klinikum Stuttgart

Stuttgart, Germany

NOT YET RECRUITING

Related Publications (1)

  • Konig 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: 34930368DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Klaus Herfarth, Prof. Dr.

CONTACT

+49 6221 56 34093studienkoordination.RAD@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr. Jürgen Debus

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 12, 2021

Study Start

April 19, 2021

Primary Completion (Estimated)

September 19, 2030

Study Completion (Estimated)

January 19, 2033

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

DE(3)