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Search / Trial NCT06093165

RE-irradiation of Diffuse MIdline Glioma paTients

Launched by RIGSHOSPITALET, DENMARK · Oct 16, 2023

Trial Information

Current as of November 13, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The REMIT study is looking at the safety and effectiveness of giving radiation treatment again to patients with diffuse midline glioma, a type of brain tumor that often affects children and young adults. This study aims to create a standard schedule for this second round of radiation for patients whose condition has worsened after their initial treatment. Researchers hope to find ways to help manage symptoms and improve the quality of life for these patients.

To be eligible for the study, participants must be between 12 months and 21 years old and have been diagnosed with diffuse midline glioma. They should have completed their first round of radiation therapy at least six months ago and be showing signs that their condition is getting worse. Participants will need to be in good enough health to tolerate another treatment and have the support of a parent or guardian to join the study. If you or someone you know meets these criteria, the study team will provide more information about what to expect during the trial, including any follow-up appointments and care needed.

Gender

ALL

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)

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Patients applied

0 patients applied

Trial Officials

Maja V Maraldo

Principal Investigator

Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported