Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
59 participants
INTERVENTIONAL
2023-10-31
2029-11-30
Brief Summary
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Detailed Description
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Patients treated with primary radiotherapy 54Gy/30 fractions, either enrolled in the BIOMEDE 2.0 protocol or not, will be included in Arm A. DMG patients treated with any other total dose and fractionation than 54Gy/30F will be included in Arm B. The re-RT and follow up will be the same in both arms.
As treatment 20Gy/10 fractions is given as first time re-irradiation with extended follow up on toxicity, performance status and quality of life.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Primary radiotherapy 54Gy/30 fractions
Re-irradiation
20Gy on 10 fractions
B
Any other dose and fractionation for primary radiotherapy than 54gy/30 fractions.
Re-irradiation
20Gy on 10 fractions
Interventions
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Re-irradiation
20Gy on 10 fractions
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 12 months to ≤21 years.
* Min. 180 days/6 months have elapsed from the first day of the 1st RT course
* 1st 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
Exclusion Criteria
* 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)
12 Months
21 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Karolinska University Hospital
OTHER
Radiumhospitalet, Oslo University Hospital
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
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Maja Maraldo
Consultant, Head of breast and paediatric radiotherapy
Principal Investigators
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Maja V Maraldo
Role: PRINCIPAL_INVESTIGATOR
Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
Central Contacts
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References
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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.
Other Identifiers
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REMIT
Identifier Type: -
Identifier Source: org_study_id
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