RE-irradiation of Diffuse MIdline Glioma paTients

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RE-irradiation of Diffuse MIdline Glioma paTients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Months - 21 Years
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06093165
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rigshospitalet, Denmark
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maja V Maraldo
Principal Investigator Affiliation	Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma, Pontine Tumors, Thalamic Tumor, Brain Tumor, Pediatric

Additional Details

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.

Arms & Interventions