Studying Radiation Treatment for Brain Tumors with Midline Brain Tumors: A Phase II Trial

Craniospinal irradiation in Histone AlteRed Midline glioma (CHARM) – A Phase II Open label prospective study - CHARM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076687

Enrollment

Registered

2024-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C729- Malignant neoplasm of central nervous system, unspecified

Interventions

Intervention1: Craniospinal Irradiation: Craniospinal irradiation involves delivery of radiation therapy to the whole brain, spinal cord, nerve roots, the covering meninges(leptomeninges) and subarach

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed biopsy proven histone altered diffuse midline glioma 2.Age-More than equal to 3 to less than 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

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

Design outcomes

Primary

Measure	Time frame
Overall survivalTimepoint: at 12 months	—

Secondary

Measure	Time frame
Time to leptomeningeal dissemination in months - Incidence of different failure patterns from clinico-radiological assessment - Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) during CSI(weekly), at conclusion of radiotherapy , post completion of 6 cycles adjuvant temozolomide, and in subsequent follow-ups at 3, 6, 9 and 12 months. - Quality of life indices using the EORTC QLQC- 30 and its BN -20 module at baseline, after completion of radiotherapy, post completion of 6 cycles adjuvant temozolomide and in subsequent follow-up visits at 3, 6, 9 and 12 months. - Quality of life without symptoms or toxicity in three health states TOX (toxicity), TWIST (time without symptoms) and REL (relapse) at baseline, after completion of radiotherapy, post completion of 6 cycles adjuvant temozolomide and in subsequent follow-up visits at 3, 6, 9 and 12 months. Timepoint: subsequent follow-up visits at 3, 6, 9 and 12 months.	—

Measure

Time frame

Time to leptomeningeal dissemination in months - Incidence of different failure patterns from clinico-radiological assessment - Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) during CSI(weekly), at conclusion of radiotherapy , post completion of 6 cycles adjuvant temozolomide, and in subsequent follow-ups at 3, 6, 9 and 12 months. - Quality of life indices using the EORTC QLQC- 30 and its BN -20 module at baseline, after completion of radiotherapy, post completion of 6 cycles adjuvant temozolomide and in subsequent follow-up visits at 3, 6, 9 and 12 months. - Quality of life without symptoms or toxicity in three health states TOX (toxicity), TWIST (time without symptoms) and REL (relapse) at baseline, after completion of radiotherapy, post completion of 6 cycles adjuvant temozolomide and in subsequent follow-up visits at 3, 6, 9 and 12 months. Timepoint: subsequent follow-up visits at 3, 6, 9 and 12 months.

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Countries

India

Contacts

Public ContactDr Abhishek Chatterjee

chatterji08@gmail.com0224176015

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026