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NCT06093165Not yet recruiting

RE-irradiation of Diffuse MIdline Glioma paTients

Source: ClinicalTrials.gov · Last updated 23 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
59 (estimated)
First submitted
8 Sept 2023
Start date
Oct 2023
Primary completion date
Nov 2029
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
NCT number
NCT06093165

What you commit to

  • Study type: Interventional
  • Planned participants: 59
  • From Oct 2023 to the primary completion date, Nov 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \>1 course of radiotherapy

Other illness

  • Presence of leptomeningeal spread or multifocal disease on MRI at progression

Other

  • Other co-morbidity that according to the treating physician would impair participation in the study
  • Neurofibromatosis type 1
  • Inability to complete the medical follow-up (geographic, social, or mental reasons)

Who the study is looking for

  • 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

Age in the registry: 12 months to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.