RE-irradiation of Diffuse MIdline Glioma paTients (REMIT)

Rigshospitalet

Status: Not yet enrolling

Conditions: Diffuse Glioma; Pontine Tumors; Brain Tumor, Pediatric; Diffuse Intrinsic Pontine Glioma; Thalamic Tumor; Diffuse Midline Glioma, H3 K27M-Mutant

Treatments: Radiation: Re-irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT06093165

REMIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 estimated patients

Sex: All

Ages: 12 months to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

A

Other group

Description:

Primary radiotherapy 54Gy/30 fractions

Treatment:

Radiation: Re-irradiation

B

Other group

Description:

Any other dose and fractionation for primary radiotherapy than 54gy/30 fractions.

Treatment:

Radiation: Re-irradiation