Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients

NCT05768087 | Recruiting DMC

• 1 other identifier: 1-10-72-190-22
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  CTCAE version 5.0

  up til 2 years after the end of proton therapy

• Dose Limiting Toxicities

  CTCAE version 5.0

  up til 6 months after the start of proton therapy

Study Arms (1)

Escalated proton therapy

EXPERIMENTAL

Radiation: Escalated proton therapy

Interventions

Escalated proton therapy RADIATION

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

Escalated proton therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Cancer Society: collaborator

Study Sites (2)

Aarhus University Hospital, Dept. of Oncology

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Danish Centre for Particle Therapy

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Anouk K Trip, MD PhD

  Danish Centre for Particle Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit K Bach

CONTACT

+4529797231; dcpt_kfe@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)