Clinical Trial

Craniospinal Irradiation in Histone AlteRed Midline Glioma

Study acronym: CHARM
Recruiting
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Summary
Paediatric H3K27/H3G34 mutant diffuse midline gliomas are high grade gliomas that arise in midline structures/cerebral hemispheres and are known to have dismal outcomes. Standard treatment includes definitive radiation therapy to primary site along with concurrent temozolomide chemotherapy following histological confirmation with a biopsy. Studies have shown poorer outcomes in the paediatric age group compared to that of adults and an increased risk to fail/recur in the leptomeninges(covering of brain and spinal cord). The following study is planned in order to assess the benefit of craniospinal irradiation(delivering radiotherapy to brain, spinal cord and its covering membrane in this high risk population. Thereby the investigator aim to improve survival in newly diagnosed histone mutant pediatric midline gliomas in the upfront setting. Patterns of disease failure, treatment related toxicities and quality of life will also be assessed as a part of this study. If proven beneficial, this study will influence how patients with this diagnosis will be treated in the future.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-02.
Status change: Not Yet Recruiting → Recruiting 2025-01-16
Trial Details
NCT Number NCT06720727
Lead Sponsor Tata Memorial Centre
Conditions Glioma
Enrollment 32 participants
Start Date 2025-01-03
Primary Completion 2028-11-08 (estimated)
Study Completion 2028-11-08 (estimated)
Updated on ClinicalTrials.gov 2025-01-20