Diffuse Midline Glioma, H3 K27M-MutantREMITNCT06093165
RE-irradiation of Diffuse MIdline Glioma paTients
A study testing Re-irradiation in people with Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 21 years
- Conditions the study is for
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma
- What is being tested?
- Re-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma, Pontine Tumors, Thalamic Tumor, Brain Tumor, Pediatric
- Being tested
- Re-irradiation
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma, Brain Stem Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-irradiationRadiation
20Gy on 10 fractions
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Primary radiotherapy 54Gy/30 fractions Receives: Radiation: Re-irradiation |
| B | Other | Any other dose and fractionation for primary radiotherapy than 54gy/30 fractions. Receives: Radiation: Re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of re-irradiation (reRT)
The primary endpoint will be the cumulative incidence of grade ≥4 CTCAE (The NCI Common Terminology Criteria for Adverse Events) events measured 4 weeks after the last day of reRT.
Measured: 4 weeks after end of re-irradiation
Secondary outcomes (3)
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.
Palliative efficacy measured as overall survival will be reported as 1) from date of diagnosis to date of death by any cause, and 2) from date of first radiological and/or clinical progression to date of death by any cause.
Measured: 4 weeks after end of re-irradiation
Palliative efficacy measured as symptom relief
Symptom relief measured by 1) clinical performance status (Karnofsky or Lansky) assessed every second week, 2) a modified PEDI score before, during and 4 weeks after reRT, 3) steroid dose levels measured every second week, and 4) quality of life monitored before, during and 4 weeks after re-irradiation with PedsQL Cancer module questionnaire.
Measured: 4 weeks after end of re-irradiation
Other secondary outcomes
Other secondary objectives are further defined as:
- Image-guided characterization of the anatomical site of progression compared to the primary lesion.
- Assessment of cumulated radiation dose to critical structures in the brain following the initial and reRT treatment.
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Midline Glioma, H3 K27M-MutantStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Sahlgrenska University Hospital, Karolinska University Hospital, Oslo University Hospital
- Responsible party
- Principal investigator, Maja Maraldo, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Maja V Maraldo, Principal investigator, Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093165
- Sponsor's protocol ID
- REMIT
- Acronym
- REMIT
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be collected in a RedCap database.
Publications
Ostergaard DE, Embring A, Sehested A, Magelssen H, Vogelius IR, Kjaersgaard M, Nysom K, Mathiasen R, Lukacova S, Maraldo MV. REMIT: Reirradiation of Diffuse Midline Glioma Patients -A Nordic Society of Paediatric Haematology and Oncology Feasibility Study. Clin Oncol (R Coll Radiol). 2025 Jan;37:103682. doi: 10.1016/j.clon.2024.103682. Epub 2024 Nov 6.
PubMed 39626445
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RE-irradiation of Diffuse MIdline Glioma paTients
- ClinicalTrials.gov ID
- NCT06093165
- Acronym / sponsor ID
- REMIT / REMIT
- Conditions
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma, Pontine Tumors, Thalamic Tumor, Brain Tumor, Pediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Sahlgrenska University Hospital, Karolinska University Hospital, Oslo University Hospital
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Radiation: Re-irradiationPrimary radiotherapy 54Gy/30 fractions |
| B | Other | Radiation: Re-irradiationAny other dose and fractionation for primary radiotherapy than 54gy/30 fractions. |
Who may qualify
- Ages
- 12 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-irradiation20Gy on 10 fractions | Radiation | A, B |
Primary outcome
To evaluate the safety of re-irradiation (reRT)
Time frame: 4 weeks after end of re-irradiation
The primary endpoint will be the cumulative incidence of grade ≥4 CTCAE (The NCI Common Terminology Criteria for Adverse Events) events measured 4 weeks after the last day of reRT.
3 secondary outcomes
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.
Time frame: 4 weeks after end of re-irradiation
Palliative efficacy measured as symptom relief
Time frame: 4 weeks after end of re-irradiation
Other secondary outcomes
Time frame: through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39626445Ostergaard DE, Embring A, Sehested A, Magelssen H, Vogelius IR, Kjaersgaard M, Nysom K, Mathiasen R, Lukacova S, Maraldo MV. REMIT: Reirradiation of Diffuse Midline Glioma Patients -A Nordic Society of Paediatric Haematology and Oncology Feasibility Study. Clin Oncol (R Coll Radiol). 2025 Jan;37:103682. doi: 10.1016/j.clon.2024.103682. Epub 2024 Nov 6.
- Individual participant dataSharing planned: No. All data will be collected in a RedCap database.
Related trials for Diffuse Midline Glioma, H3 K27M-Mutant
RecruitingPhase 2
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
RecruitingObservational study
International Diffuse Intrinsic Pontine Glioma (DIPG)/Diffuse Midline Glioma (DMG) Registry and Repository
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingPhase 3
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
RecruitingPhase 1
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maja V Maraldo principal investigator
Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Re-irradiation in people with Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniella Østergaard (+4520822297, daniella.elisabet.oestergaard.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of re-irradiation (reRT) (time frame: 4 weeks after end of re-irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06093165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.