Glioblastoma Radiotherapy Using IMRT or Proton Beams (GRIPS)

University Hospital Heidelberg

Status: Enrolling

Conditions: Glioblastoma

Treatments: Radiation: Proton irradiation; Radiation: Photon irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04752280

GRIPS

Details and patient eligibility

About

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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

Arm A: Proton irradiation

Experimental group

Description:

Irradiation applied with protons

Treatment:

Radiation: Proton irradiation

Arm B: Photon IMRT

Active Comparator group

Description:

Photon irradiation applied as intensity-modulated radiotherapy

Treatment:

Radiation: Photon irradiation