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Glioblastoma Radiotherapy Using IMRT or Proton Beams (GRIPS)

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ClinicalTrials.gov Identifier: NCT04752280
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Radiation: Proton irradiation Radiation: Photon irradiation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glioblastoma Radiotherapy Using IMRT or Proton Beams
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : August 19, 2025
Estimated Study Completion Date : October 19, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Proton irradiation
Irradiation applied with protons
 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)
Active Comparator: Arm B: Photon IMRT
Photon irradiation applied as intensity-modulated radiotherapy
 Radiation: Photon irradiation
proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative rate of toxicity [ Time Frame: from start of radiotherapy until progress (max. month 4) ]
    Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 1 year and 2 years ]
    Progression free survival

  2. Overall survival [ Time Frame: 1 year and 2 years ]
    Overall survival

  3. Acute Toxicity [ Time Frame: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4) ]
    according to CTC AE V5.0

  4. Late Toxicity [ Time Frame: 6 weeks after end of therapy (end of therapy up to month 4) ]
    according to CTC AE V5.0

  5. Quality of life according to EORTC QLQ-C30 [ Time Frame: 1 year and 2 years ]
    according to EORTC QLQ-C30

  6. Quality of life according to EORTC QLQ-BN20 [ Time Frame: 1 year and 2 years ]
    according to EORTC QLQ-BN20

  7. Neurocognition [ Time Frame: 1 year and 2 years ]
    according to Hopkins Verbal Learning Test-Revised

  8. Measuring number of Lymphocytes count [ Time Frame: end of therapy up to month 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752280


Contacts
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Contact: Klaus Herfarth, Prof. Dr. +49 6221 56 34093 studienkoordination.RAD@med.uni-heidelberg.de

Locations
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Germany
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Klaus Herfarth, Prof. Dr.         
Universitätsklinikum Gießen und Marburg Not yet recruiting
Marburg, Germany
Contact: Rita Engenhart-Cabillic, Prof. Dr.         
Klinikum Stuttgart Not yet recruiting
Stuttgart, Germany
Contact: Marc Münter, Prof. Dr.         
Sponsors and Collaborators
University Hospital Heidelberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juergen Debus, Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04752280    
Other Study ID Numbers: GRIPS
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue