NCT06720727

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2025Nov 2028

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

January 3, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2028

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

October 30, 2024

Last Update Submit

January 16, 2025

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

  • Survival Outcomes

    Overall survival- time in months between the date of diagnosis to date of death due to any cause

    at 12 months

Secondary Outcomes (6)

  • Leptomeningeal Dissemination

    at 12 months

  • Patterns of failure

    at 12 months

  • Any treatment emergent acute toxicity recording

    Baseline , week 1 , week 2 , week 3 , week 4 , week 5 ,week 6 , conclusion of RT

  • Quality of life indices

    will be done at 3 months

  • QTWiST (Quality of life Without Symptoms or Toxicity) calculation

    will be done at 3 months

  • +1 more secondary outcomes

Study Arms (1)

Single arm

EXPERIMENTAL

Craniospinal irradiation involves delivery of radiation therapy to the whole brain, spinal cord, nerve roots, the covering meninges(leptomeninges) and subarachnoid space and provides a viable means of mitigating leptomeningeal spread and possibly improving survival.

Radiation: craniospinal irradiation

Interventions

craniospinal irradiationRADIATION

Delivering radiotherapy to brain, spinal cord and its covering membrane.

Single arm

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, India

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Craniospinal Irradiation

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Abhishek Chatterjee, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhishek Chatterjee, MD

CONTACT

2224177000chatterji08@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

December 6, 2024

Study Start

January 3, 2025

Primary Completion (Estimated)

November 8, 2028

Study Completion (Estimated)

November 8, 2028

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)