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Trial Title:
RE-irradiation of Diffuse MIdline Glioma paTients
NCT ID:
NCT06093165
Condition:
Diffuse Midline Glioma, H3 K27M-Mutant
Diffuse Intrinsic Pontine Glioma
Diffuse Glioma
Pontine Tumors
Thalamic Tumor
Brain Tumor, Pediatric
Conditions: Official terms:
Glioma
Diffuse Intrinsic Pontine Glioma
Brain Stem Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Primary radiotherapy treatment
Intervention:
Intervention type:
Radiation
Intervention name:
Re-irradiation
Description:
20Gy on 10 fractions
Arm group label:
A
Arm group label:
B
Summary:
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.
Detailed 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.
Criteria for 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)
Gender:
All
Minimum age:
12 Months
Maximum age:
21 Years
Healthy volunteers:
No
Start date:
October 2023
Completion date:
November 2029
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Sahlgrenska University Hospital, Sweden
Agency class:
Other
Collaborator:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
Radiumhospitalet, Oslo University Hospital
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093165
