Glioblastoma Radiotherapy Using IMRT or Proton Beams

Not Applicable

Recruiting

• Conditions: Glioblastoma
• Interventions: Radiation: Photon irradiation; Radiation: Proton irradiation

• Registration Number: NCT04752280
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-12
• Study Start: 2021-04-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-08-19
• Study Completion: 2027-10-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Photon IMRT	Photon irradiation	Photon irradiation applied as intensity-modulated radiotherapy
Arm A: Proton irradiation	Proton irradiation	Irradiation applied with protons

Primary Outcome Measures

Name	Time	Method
Cumulative rate of toxicity	from start of radiotherapy until progress (max. month 4)	Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year and 2 years	Overall survival
Late Toxicity	6 weeks after end of therapy (end of therapy up to month 4)	according to CTC AE V5.0
Acute Toxicity	start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)	according to CTC AE V5.0
Quality of life according to EORTC QLQ-BN20	1 year and 2 years	according to EORTC QLQ-BN20
Quality of life according to EORTC QLQ-C30	1 year and 2 years	according to EORTC QLQ-C30
Measuring number of Lymphocytes count	end of therapy up to month 4
Progression free survival	1 year and 2 years	Progression free survival
Neurocognition	1 year and 2 years	according to Hopkins Verbal Learning Test-Revised

Trial Locations

Locations (3)

Universitätsklinikum Gießen und Marburg; 🇩🇪 Marburg, Germany

Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany