Escalated dose proton therapy for glioblastoma patients
Official title: Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients - A Phase 1 Proton Dose Finding Trial -
Run by University of Aarhus · NCT05768087 · Data updated 2026-11-12
This study is testing higher doses of proton therapy for patients with glioblastoma to find out the safest amount they can tolerate while receiving other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Aarhus, Central Jutland and 1 other locations) |
| Status | Recruiting |
| Started | April 15, 2024 |
| Main results expected | October 2026 |
| Study ends | May 2029 |
| Registry record updated | May 9, 2024 |
| Trial ID | NCT05768087 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with newly diagnosed, contrast-enhancing glioblastoma eligible for surgical resection.
✕Probably not a fit
Patients with contraindications to MRI or Gadolinium contrast, or those not meeting the inclusion criteria, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 trial aims to determine the maximum tolerated dose of escalated proton therapy in patients with glioblastoma undergoing multimodality treatment. Patients will receive proton therapy with increasing doses while being closely monitored for safety and tolerability. The study will categorize patients based on the volume of their radiation target and utilize a continuous reassessment method to identify the maximum tolerated dose. The trial will conclude once the maximum tolerated dose is established, followed by an expansion cohort for further evaluation.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and safety for glioblastoma patients.
How similar studies have gone: While the use of proton therapy is established, this specific escalated dose approach in glioblastoma is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (main): * Newly diagnosed, contrast-enhancing GBM, IDHwt (WHO 2021 classification). * Maximal safe surgical resection is required; any extent of surgical resection is allowed (including biopsy-only). * Patient with target volume and location eligible for 60 Gy chemoradiotherapy. * Minimum distance between GTV and critical OAR (brainstem, chiasm, optic nerves and tracts in case of serviceable vision) of 5 mm on MRI-scan. * Age ≥ 18 years. * Karnofsky Performance Status grade of ≥ 70. * Adequate blood counts as assessed by treating physician. * Absence of any contraindication to undergo MRI and/or to receive Gadolinium contrast agent. * Before patient registration, written informed consent must be given according to Good Clinical Practice, and national/local regulations. Exclusion Criteria: * All eligibility criteria are formulated as inclusion criteria.
Where it's running
-
Aarhus University Hospital, Dept. of Oncology
Aarhus, Central Jutland, Denmark Recruiting -
Danish Centre for Particle Therapy
Aarhus, Denmark Recruiting
Study contacts
- Principal investigator: Anouk K Trip, MD PhD — Danish Centre for Particle Therapy
- Study coordinator: Birgit K Bach
- Email: dcpt_kfe@rm.dk
- Phone: +4529797231
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
YN003 injection in glioma patients
This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.
-
Brain connectome project in adults with brain glioma undergoing surgery
This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.
-
Lixumistat window of opportunity in newly diagnosed glioblastoma
This study tests whether Lixumistat can benefit adults with newly diagnosed glioblastoma who are planned for surgical tumor removal.
-
Glioblastoma in Réunion: an epidemiological and socio-anthropological look at patients and care
A large group of adults with diffuse gliomas in Réunion is being studied to understand how biology, culture, and health care pathways affect diagnosis and treatment.
-
Butterfly glioblastoma: test adding 5-ALA PoMA with LIDU ultrasound to standard care
This early-phase study tests whether adding 5-ALA–mediated activation with LIDU ultrasound is safe and tolerable for adults with newly diagnosed butterfly glioblastoma, before or during standard chemotherapy and radiotherapy.
-
Maintenance radiotherapy after standard glioblastoma treatment
This study tests whether a single 2 Gy maintenance radiotherapy dose after standard treatment is safe and feasible for adults with newly diagnosed glioblastoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.