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NCT06720727Recruiting

Craniospinal Irradiation in Histone AlteRed Midline Glioma

Craniospinal Irradiation in Histone AlteRed Midline Glioma (CHARM) - A Phase II Open Label Prospective Study

Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
32 (estimated)
First submitted
30 Oct 2024
Start date
3 Jan 2025
Primary completion date
8 Nov 2028
Lead sponsor
Tata Memorial Centre
NCT number
NCT06720727

What you commit to

  • Study type: Interventional
  • Planned participants: 32
  • From 3 Jan 2025 to the primary completion date, 8 Nov 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not willing /unlikely to comply with proposed therapy and follow up

Other illness

  • Recurrent or progressive disease
  • Clinical features or family history suggestive of Inherited Cancer Predisposition such as Constitutional Mismatch Repair Deficiency (CMMRD)
  • Previous history of malignancy

Who the study is looking for

  • Newly diagnosed biopsy proven histone altered diffuse midline glioma
  • Age- ≥3 to \<18 years at time of diagnosis
  • Karnofsky/Lansky Performance Score more than or equal to 70
  • Has provided written informed consent/ assent form
  • No prior therapy except debulking surgery or biopsy

Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tata Memorial Hospital
Coordinator of this site? Confirm its status
MumbaiIndiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.