Clinical trial NCT06093165: RE-irradiation of Diffuse MIdline Glioma paTients
Official title: RE-irradiation of Diffuse MIdline Glioma paTients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diffuse Midline Glioma, H3 K27M-Mutant
Diffuse Intrinsic Pontine Glioma
Diffuse Glioma
Pontine Tumors
Thalamic Tumor
Brain Tumor, Pediatric
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Sahlgrenska University Hospital
name: Karolinska University Hospital
name: Radiumhospitalet, Oslo University Hospital
First posted: 2023-10-23
Enrollment: 59
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: To evaluate the safety of re-irradiation (reRT)
timeFrame: 4 weeks after end of re-irradiation
Secondary outcomes:
measure: The key secondary objective is to prospectively validate the palliative efficacy of reRT of DMG. Palliative efficacy is evaluated by two endpoints: overall survival and symptom relief.
timeFrame: 4 weeks after end of re-irradiation
measure: Palliative efficacy measured as symptom relief
timeFrame: 4 weeks after end of re-irradiation
measure: Other secondary outcomes
timeFrame: through study completion
Other outcomes:
measure: Exploratory analyses
timeFrame: through study completion
Locations:
Study officials:
affiliation: Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
name: Maja V Maraldo
role: PRINCIPAL_INVESTIGATOR
References: