Actively Recruiting

Phase Not Applicable
Age: 3Years - 18Years
All Genders
NCT06720727

Craniospinal Irradiation in Histone AlteRed Midline Glioma

Led by Tata Memorial Centre · Updated on 2025-01-20

32

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Craniospinal Irradiation in Histone AlteRed Midline Glioma

Who Can Participate

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed biopsy proven histone altered diffuse midline glioma
  • Age 3 to less than 18 years at time of diagnosis
  • Karnofsky/Lansky Performance Score of 70 or higher
  • Provided written informed consent or assent
  • No prior therapy except debulking surgery or biopsy
Not Eligible

You will not qualify if you...

  • Recurrent or progressive disease
  • Clinical features or family history indicating inherited cancer predisposition such as Constitutional Mismatch Repair Deficiency (CMMRD)
  • Previous history of malignancy
  • Unwilling or unlikely to comply with proposed therapy and follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tata Memorial Hospital

Mumbai, India

Actively Recruiting

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Research Team

A

Abhishek Chatterjee, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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