RE-irradiation of Diffuse MIdline Glioma paTients

RE-irradiation of Diffuse MIdline Glioma paTients

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.

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.

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)