Glioblastoma Radiotherapy Using IMRT or Proton Beams

ConditionGlioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically confirmed gliomblastoma WHO IV (operated or after biopsy)

Indication for radiotherapy / radiochemotherapy

Informed consent

KI ≥ 60% or ECOG 0/1

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

326 Participants
are divided into 2 treatment groups
Group A: Arm A: Proton irradiationExperimental treatment 1 intervention
Group B: Arm B: Photon IMRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative rate of toxicity

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

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

Secondary outcomes

1

Progression free survival

Progression free survival

Time frame
1 year and 2 years
2

Overall survival

Overall survival

Time frame
1 year and 2 years
3

Acute Toxicity

according to CTC AE V5.0

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

Late Toxicity

according to CTC AE V5.0

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

Other outcomes

Sponsors and contacts

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