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Not yet recruiting NCT06093165

RE-irradiation of Diffuse MIdline Glioma paTients

No phase Interventional Diffuse Midline Glioma, H3 K27M-Mutant Diffuse Intrinsic Pontine Glioma Diffuse Glioma Pontine Tumors

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Re-irradiation.
Who it may be relevant to
Registry conditions: Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma, Pontine Tumors. Basic parameters: 12 months — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

REMIT is a non-randomized, prospective, investigator-initiated, phase II, multi-centre observational study with two inclusion groups, arm A and B. Arm A and B will be offered the same treatment.

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.

Interventions

  • Radiation Re-irradiation
    20Gy on 10 fractions

Primary outcome measures

  • To evaluate the safety of re-irradiation (reRT) [Time frame: 4 weeks after end of re-irradiation]
Secondary outcome measures (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. [Time frame: 4 weeks after end of re-irradiation]
  • Palliative efficacy measured as symptom relief [Time frame: 4 weeks after end of re-irradiation]
  • Other secondary outcomes [Time frame: through study completion]

Eligibility criteria

Inclusion criteria

  • 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
  • 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

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 39626445

Identifiers

NCT: NCT06093165 · REMIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗