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NCT Number: NCT04752280

Glioblastoma Radiotherapy Using IMRT or Proton Beams

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Heidelberg, Heidelberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton irradiation

Radiation

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

Photon irradiation

Radiation

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

Primary outcomes

  1. Cumulative rate of toxicity

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

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

Secondary outcomes

  1. Progression free survival

    Time frame: 1 year and 2 years

    Progression free survival

  2. Overall survival

    Time frame: 1 year and 2 years

    Overall survival

  3. Acute Toxicity

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

    according to CTC AE V5.0

  4. Late Toxicity

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

    according to CTC AE V5.0

  5. Quality of life according to EORTC QLQ-C30

    Time frame: 1 year and 2 years

    according to EORTC QLQ-C30

  6. Quality of life according to EORTC QLQ-BN20

    Time frame: 1 year and 2 years

    according to EORTC QLQ-BN20

  7. Neurocognition

    Time frame: 1 year and 2 years

    according to Hopkins Verbal Learning Test-Revised

  8. Measuring number of Lymphocytes count

    Time frame: end of therapy up to month 4

Study contacts

Contact information is provided by the study sponsor or research team.

Klaus Herfarth, Prof. Dr.

CONTACT

[email protected]

+49 6221 56 311584 ext. 34091

Laila König, Prof. Dr.

CONTACT

[email protected]

+49 6221 56 36318 ext. 36318

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: GRIPS

Important dates

Study start
2021
Primary completion
2030
Study completion
2033
First posted
Feb 12, 2021
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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