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Trial Title:
Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients
NCT ID:
NCT05768087
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Escalated proton therapy
Description:
According to allocated dose level: level 1-8, 69-90 Gy in 30 fractions of 2.3-3.0 Gy, to
a subvolume of the radiation target
Arm group label:
Escalated proton therapy
Summary:
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.
Detailed description:
This is a prospective, single-arm, phase 1 proton dose finding trial, aiming to assess
the clinical tolerability and safety of escalated dose proton therapy (PT) in
glioblastoma (GBM) patients, according to treatment volume. Radiotherapy will be
administered with protons for the entire treatment, escalating the proton fraction-dose
with the overall treatment time unchanged. The escalated proton dose will be prescribed
to a subvolume of the radiation target. Escalated PT will be employed within the
multimodality treatment; surgical procedures and concomitant and adjuvant chemotherapy
follow the standard-of-care.
Patients will be subdivided in two groups based on the volume of the radiation target:
patients with a CTV2 volume of <200 cc will be placed in group 1 and those with a volume
≥ 200 cc in group 2. Per group, proton dose will be escalated stepwise, which will be
guided by a time to event continuous reassessment method (TiTE-CRM) to identify the MTD
in this specific combination treatment.
The MTD in this trial is defined as the highest proton dose level at which no more than
30% of the patients develop dose limiting toxicities (DLTs) assessed up to 6 months after
the start of PT.
Patient accrual to the main (dose escalation) part of the study ends when the MTD has
been identified. If the statistically recommended MTD is declared, an expansion cohort to
a total of 6 patients treated at the MTD and 6 patients at the MTD-1 (i.e. 1 dose level
below MTD) will be considered. When all patients have been followed for toxicity for at
least 1 year after the end of PT (and to a maximum of 2 years), the recommended phase 2
dose (RP2D) will be determined based on the full toxicity profile.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital, Dept. of Oncology
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Anne Helland Christiansen
Investigator:
Last name:
Slavka Lukacova, MD PhD
Email:
Principal Investigator
Facility:
Name:
Danish Centre for Particle Therapy
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Birgit K Bach
Phone:
+4529797231
Email:
dcpt_kfe@rm.dk
Investigator:
Last name:
Anouk K Trip, MD PhD
Email:
Principal Investigator
Start date:
April 15, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768087
