Glioblastoma Radiotherapy Using IMRT or Proton Beams

Glioblastoma Clinical Trial

— GRIPS  

Official title:

Glioblastoma Radiotherapy Using IMRT or Proton Beams

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752280
• Other study ID #: GRIPS
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: October 19, 2027

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Klaus Herfarth, Prof. Dr.
• Phone: +49 6221 56 34093
• Email: studienkoordination.RAD[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: October 19, 2027
• Est. primary completion date: August 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Gießen und Marburg	Marburg
Germany	Klinikum Stuttgart	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative rate of toxicity	Cumulative rate of toxicity = grade 2 (until progress (max. month 4))	from start of radiotherapy until progress (max. month 4)
Secondary	Progression free survival	Progression free survival	1 year and 2 years
Secondary	Overall survival	Overall survival	1 year and 2 years
Secondary	Acute Toxicity	according to CTC AE V5.0	start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)
Secondary	Late Toxicity	according to CTC AE V5.0	6 weeks after end of therapy (end of therapy up to month 4)
Secondary	Quality of life according to EORTC QLQ-C30	according to EORTC QLQ-C30	1 year and 2 years
Secondary	Quality of life according to EORTC QLQ-BN20	according to EORTC QLQ-BN20	1 year and 2 years
Secondary	Neurocognition	according to Hopkins Verbal Learning Test-Revised	1 year and 2 years
Secondary	Measuring number of Lymphocytes count		end of therapy up to month 4