RE-irradiation of Diffuse MIdline Glioma paTients
REMIT
1 other identifier
interventional
59
0 countries
N/A
Brief Summary
The REMIT (RE-irradiation of diffuse MIdline glioma paTients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (DMG). The study will introduce a standard re-irradiation treatment schedule for DMG patients who have progressed following primary treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
October 23, 2023
October 1, 2023
6.1 years
September 8, 2023
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of re-irradiation (reRT)
The primary endpoint will be the cumulative incidence of grade ≥4 CTCAE (The NCI Common Terminology Criteria for Adverse Events) events measured 4 weeks after the last day of reRT.
4 weeks after end of re-irradiation
Secondary Outcomes (3)
The key secondary objective is to prospectively validate the palliative efficacy of reRT of DMG. Palliative efficacy is evaluated by two endpoints: overall survival and symptom relief.
4 weeks after end of re-irradiation
Palliative efficacy measured as symptom relief
4 weeks after end of re-irradiation
Other secondary outcomes
through study completion
Other Outcomes (1)
Exploratory analyses
through study completion
Study Arms (2)
A
OTHERPrimary radiotherapy 54Gy/30 fractions
B
OTHERAny other dose and fractionation for primary radiotherapy than 54gy/30 fractions.
Interventions
Eligibility Criteria
You may qualify if:
- Diffuse midline glioma diagnosis: verified radiologically or histologically Biopsy is not mandatory for REMIT
- Age ≥ 12 months to ≤21 years.
- Min. 180 days/6 months have elapsed from the first day of the 1st RT course
- st course of radiotherapy
- Full recovery from all acute and subacute toxicities of 1st RT course
- Clinical progression of symptoms and/or radiographic progression
- Karnofsky performance status scale or Lansky Play Scale \> 50% The performance status should not take the neurological deficits per se into account.
- NB: Children and adults with a worsening performance status due to glioma-related motor deficit can be included.
- Life expectancy \> 12 weeks after start of reRT
- Signed informed consent by patient and/or parents or legal guardian
You may not qualify if:
- Presence of leptomeningeal spread or multifocal disease on MRI at progression
- Other co-morbidity that according to the treating physician would impair participation in the study
- \>1 course of radiotherapy
- Neurofibromatosis type 1
- Inability to complete the medical follow-up (geographic, social, or mental reasons)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Aarhus University Hospitalcollaborator
- Sahlgrenska University Hospitalcollaborator
- Karolinska University Hospitalcollaborator
- Radiumhospitalet, Oslo University Hospitalcollaborator
Related Publications (1)
Ostergaard DE, Embring A, Sehested A, Magelssen H, Vogelius IR, Kjaersgaard M, Nysom K, Mathiasen R, Lukacova S, Maraldo MV. REMIT: Reirradiation of Diffuse Midline Glioma Patients -A Nordic Society of Paediatric Haematology and Oncology Feasibility Study. Clin Oncol (R Coll Radiol). 2025 Jan;37:103682. doi: 10.1016/j.clon.2024.103682. Epub 2024 Nov 6.
PMID: 39626445DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maja V Maraldo
Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Primary radiotherapy treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, Head of breast and paediatric radiotherapy
Study Record Dates
First Submitted
September 8, 2023
First Posted
October 23, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
October 23, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
All data will be collected in a RedCap database.