Craniospinal Irradiation in Histone Altered Midline Glioma A Phase II Open Label Prospective Study in Pediatric Patients

What this Trial Is About

This research focuses on pediatric patients aged 3 to under 18 years with newly diagnosed H3K27/H3G34 mutant diffuse midline gliomas, which are aggressive high-grade brain tumors affecting midline structures and cerebral hemispheres. These tumors have poor outcomes in children, with a high risk of recurrence and spread to the leptomeninges, the membranes covering the brain and spinal cord. The study aims to evaluate whether adding craniospinal irradiation to the current standard treatment can improve survival and reduce disease spread in this high-risk group. Participants will receive craniospinal irradiation, a radiation therapy that targets the brain, spinal cord, and their covering membranes, in addition to standard treatments that include radiation to the primary tumor site and concurrent chemotherapy with temozolomide. The study is a Phase II open-label prospective trial conducted in a radiation oncology setting, assessing this more intensive radiation approach as an upfront treatment option. Throughout the study, children will be closely monitored with clinical and radiological assessments to track survival at 12 months, timing and patterns of disease spread, and treatment side effects using standard toxicity criteria. Quality of life will also be evaluated at baseline and multiple points during and after treatment using validated questionnaires. Follow-up visits will occur up to 12 months after treatment to assess long-term outcomes, including quality of life without symptoms or toxicity.

Craniospinal Irradiation in Histone AlteRed Midline Glioma