Glioblastoma Radiotherapy Using IMRT or Proton Beams

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2027-10-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Proton irradiation

Irradiation applied with protons

Group Type EXPERIMENTAL

Proton irradiation

Intervention Type RADIATION

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

Arm B: Photon IMRT

Photon irradiation applied as intensity-modulated radiotherapy

Group Type ACTIVE_COMPARATOR

Photon irradiation

Intervention Type RADIATION

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

Interventions

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Proton irradiation

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

Intervention Type RADIATION

Photon irradiation

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No