Back to resultsRE-irradiation of Diffuse MIdline Glioma paTients (REMIT)
Primary Purpose
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Re-irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Midline Glioma, H3 K27M-Mutant
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
A
B
Arm Description
Primary radiotherapy 54Gy/30 fractions
Any other dose and fractionation for primary radiotherapy than 54gy/30 fractions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT06093165
First Posted
September 8, 2023
Last Updated
October 16, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Sahlgrenska University Hospital, Sweden, Karolinska University Hospital, Radiumhospitalet, Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06093165
Brief Title
RE-irradiation of Diffuse MIdline Glioma paTients
Acronym
REMIT
Official Title
RE-irradiation of Diffuse MIdline Glioma paTients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2029 (Anticipated)
Study Completion Date
November 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Sahlgrenska University Hospital, Sweden, Karolinska University Hospital, Radiumhospitalet, Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma, Diffuse Glioma, Pontine Tumors, Thalamic Tumor, Brain Tumor, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Primary radiotherapy treatment
Allocation
Non-Randomized
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
Primary radiotherapy 54Gy/30 fractions
Arm Title
B
Arm Type
Other
Arm Description
Any other dose and fractionation for primary radiotherapy than 54gy/30 fractions.
Intervention Type
Radiation
Intervention Name(s)
Re-irradiation
Intervention Description
20Gy on 10 fractions
Primary Outcome Measure Information:
Title
To evaluate the safety of re-irradiation (reRT)
Description
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.
Time Frame
4 weeks after end of re-irradiation
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
4 weeks after end of re-irradiation
Title
Palliative efficacy measured as symptom relief
Description
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.
Time Frame
4 weeks after end of re-irradiation
Title
Other secondary outcomes
Description
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.
Time Frame
through study completion
Other Pre-specified Outcome Measures:
Title
Exploratory analyses
Description
Delineation study A comparison of variations in delineation in tumour volume among the participating institutions. This will improve the delineation-related uncertainty and, consequently, the applied margins (and hence irradiated volume) can be diminished. This will ensure a more uniform treatment across countries.
The impact of reRT on the patients and their families An analysis of the value of reRT in terms of the practical, emotional, and existential impact on patients and their families. This will be done by using a qualitative method including interviewing the parents of a subgroup of the included patients.
Referral patterns A characterisation of referral patterns of DMG patients to reRT. This will be assessed through a screenings log of all DMG patients in the participating institutions. Date of diagnosis, date of death, reRT offered yes/no, and reason for not giving reRT will be registered prospectively.
Time Frame
through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniella Østergaard
Phone
+4520822297
Email
daniella.elisabet.oestergaard.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Maja V. Maraldo
Phone
+4535451117
Email
Maja.Vestmoe.Maraldo@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maja V Maraldo
Organizational Affiliation
Department of oncology and radiotherapy, Copenhagen University Hospital Rigshospitalet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be collected in a RedCap database.
Learn more about this trial
RE-irradiation of Diffuse MIdline Glioma paTients
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