Status:
NOT_YET_RECRUITING
RE-irradiation of Diffuse MIdline Glioma paTients
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aarhus University Hospital
Sahlgrenska University Hospital
Conditions:
Diffuse Midline Glioma, H3 K27M-Mutant
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
12-21 years
Phase:
NA
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 introdu...
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. Pati...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06093165
Start Date
October 1 2023
End Date
November 1 2029
Last Update
October 23 2023
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