Craniospinal irradiation for pediatric glioma treatment
Official title: Craniospinal Irradiation in Histone AlteRed Midline Glioma (CHARM) - A Phase II Open Label Prospective Study
Run by Tata Memorial Centre · NCT06720727 · Data updated 2026-11-12
This study is testing if a special type of radiation treatment can help kids with aggressive brain tumors live longer and have a better quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Mumbai) |
| Status | Recruiting |
| Started | January 3, 2025 |
| Main results expected | November 8, 2028 |
| Study ends | November 8, 2028 |
| Registry record updated | January 20, 2025 |
| Trial ID | NCT06720727 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 18 years with newly diagnosed, biopsy-proven histone altered diffuse midline gliomas.
✕Probably not a fit
Patients with recurrent or progressive disease or those with a history of malignancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of craniospinal irradiation in improving outcomes for pediatric patients diagnosed with H3K27/H3G34 mutant diffuse midline gliomas, which are aggressive brain tumors. The research aims to enhance survival rates by delivering radiation therapy not only to the primary tumor site but also to the entire craniospinal axis. The study will assess various factors including patterns of disease failure, treatment-related toxicities, and quality of life. The primary endpoint is overall survival at 12 months, with secondary endpoints focusing on time to disease dissemination and toxicity assessments.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for children with aggressive midline gliomas.
How similar studies have gone: While similar approaches have been explored, this specific combination of craniospinal irradiation in this patient population is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newly diagnosed biopsy proven histone altered diffuse midline glioma 2. Age- ≥3 to \<18 years at time of diagnosis 3. Karnofsky/Lansky Performance Score more than or equal to 70 4. Has provided written informed consent/ assent form 5. No prior therapy except debulking surgery or biopsy Exclusion Criteria: 1. Recurrent or progressive disease 2. Clinical features or family history suggestive of Inherited Cancer Predisposition such as Constitutional Mismatch Repair Deficiency (CMMRD) 3. Previous history of malignancy 4. Not willing /unlikely to comply with proposed therapy and follow up
Where it's running
-
Tata Memorial Hospital
Mumbai, India Recruiting
Study contacts
- Principal investigator: Abhishek Chatterjee, MD — Tata Memorial Hospital
- Study coordinator: Abhishek Chatterjee, MD
- Email: chatterji08@gmail.com
- Phone: 2224177000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.