NCT05768087Recruiting
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients - A Phase 1 Proton Dose Finding Trial -
Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this phase 1 dose finding study is to to assess the clinical tolerability and safety of escalated dose proton therapy in glioblastoma patients treated with multimodality treatment, according to treatment volume. The main questions it aims to answer are: * what is the maximum tolerated proton dose in glioblastoma patients? * is the maximum tolerated proton dose in glioblastoma patients dependent on treatment volume? * what is the recommended phase 2 proton dose in glioblastoma patients? Patients will be asked to undergo radiotherapy to step-wise escalated doses using proton therapy as part of their multimodality treatment. Patients will be monitored closely for treatment effects.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 2 Mar 2023
- Start date
- 15 Apr 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Glioblastoma
- NCT number
- NCT05768087
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 15 Apr 2024 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- All eligibility criteria are formulated as inclusion criteria.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital, Dept. of Oncology Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Danish Centre for Particle Therapy Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.