NCT06720727 Craniospinal Irradiation in Histone AlteRed Midline Glioma
| NCT ID | NCT06720727 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2028-11-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-01-03 with a primary completion date of 2028-11-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Abhishek Chatterjee, MD
PRINCIPAL INVESTIGATOR
Tata Memorial Hospital
Frequently Asked Questions
Who can join the NCT06720727 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06720727 currently recruiting?
Yes, NCT06720727 is actively recruiting participants. Contact the research team at chatterji08@gmail.com for enrollment information.
Where is the NCT06720727 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06720727 clinical trial?
NCT06720727 is sponsored by Tata Memorial Centre. The principal investigator is Abhishek Chatterjee, MD at Tata Memorial Hospital. The trial plans to enroll 32 participants.