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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Karolinska University Hospital | OTHER |
| Radiumhospitalet, Oslo University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Primary radiotherapy 54Gy/30 fractions |
|
| B | Other | Any other dose and fractionation for primary radiotherapy than 54gy/30 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re-irradiation | Radiation | 20Gy on 10 fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after end of re-irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analyses |
|
Inclusion Criteria:
NB: Children and adults with a worsening performance status due to glioma-related motor deficit can be included.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniella Østergaard | Contact | +4520822297 | daniella.elisabet.oestergaard.01@regionh.dk | |
| Maja V. Maraldo | Contact | +4535451117 | Maja.Vestmoe.Maraldo@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Maja V Maraldo | Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39626445 | Derived | 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. |
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All data will be collected in a RedCap database.
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| ID | Term |
|---|---|
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| D020295 | Brain Stem Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D000069475 | Re-Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D019233 | Retreatment |
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| UNKNOWN |
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Primary radiotherapy treatment
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| 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. | 4 weeks after end of re-irradiation |
| Other secondary outcomes | Other secondary objectives are further defined as:
| through study completion |
| through study completion |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D015192 | Infratentorial Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |