NCT04752280 Glioblastoma Radiotherapy Using IMRT or Proton Beams
| NCT ID | NCT04752280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 326 participants |
| Start Date | 2021-04-19 |
| Primary Completion | 2030-09-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 326 participants in total. It began in 2021-04-19 with a primary completion date of 2030-09-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Laila König, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital of Heidelberg, Radiation Oncology
Frequently Asked Questions
Who can join the NCT04752280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04752280 currently recruiting?
Yes, NCT04752280 is actively recruiting participants. Contact the research team at studien.radonk@med.uni-heidelberg.de for enrollment information.
Where is the NCT04752280 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Marburg, Germany, Stuttgart, Germany.
Who is sponsoring the NCT04752280 clinical trial?
NCT04752280 is sponsored by University Hospital Heidelberg. The principal investigator is Laila König, Prof. Dr. at University Hospital of Heidelberg, Radiation Oncology. The trial plans to enroll 326 participants.
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