GliomaCHARMNCT06720727
Craniospinal Irradiation in Histone AlteRed Midline Glioma
A study testing craniospinal irradiation in people with Glioma, run by Tata Memorial Centre at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Glioma
- What is being tested?
- craniospinal irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 3 Jan 2025to 8 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai
Abhishek Dr Chatterjee, MD
About this study
Official title: Craniospinal Irradiation in Histone AlteRed Midline Glioma (CHARM) - A Phase II Open Label Prospective Study
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.
Read the detailed description
Introduction: Paediatric H3K27/H3G34 mutant diffuse midline gliomas (DMGs) are aggressive high-grade gliomas predominantly affecting midline structures and cerebral hemispheres. Despite aggressive therapy including radiation and chemotherapy, these tumors carry a poor prognosis, particularly in children, with frequent recurrence and high risk of leptomeningeal spread. Current standard treatment involves definitive radiation therapy to the primary site and concurrent temozolomide chemotherapy following histological confirmation via biopsy. However, outcomes remain suboptimal, prompting exploration of more intensive therapeutic strategies.
Primary objective:
To study if the addition of craniospinal irradiation to standard practice improves outcomes in pediatric diffuse midline glioma.
Secondary objectives:
- Estimate median time to leptomeningeal dissemination and compare with historical control
- Study patterns of failure
- Early and late toxicities
- Study quality of life indices
- To estimate QTWiST (Quality of life without symptoms or toxicity)
Primary endpoint: Overall survival at 12 months
Secondary endpoints:
- 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.
Study setting: The study will be conducted in the department of Radiation Oncology, Neuro Oncology Disease management group
- Conditions
- Glioma
- Being tested
- craniospinal irradiation
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
craniospinal irradiationRadiation
Delivering radiotherapy to brain, spinal cord and its covering membrane.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: craniospinal irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Outcomes
Overall survival- time in months between the date of diagnosis to date of death due to any cause
Measured: at 12 months
Secondary outcomes (6)
Leptomeningeal Dissemination
Time to leptomeningeal dissemination (will be defined as time in months between completion of planned therapy to the date of confirmation of leptomeningeal metastasis)
Measured: at 12 months
Patterns of failure
Incidence of different patterns of failure from diagnosis ( the time point of measurement of the primary outcome - overall survival
Measured: at 12 months
Any treatment emergent acute toxicity recording
All treatment emergent acute toxicity- expected (nausea, vomiting, hematological, dermatitis and mucositis) and unexpected, will be recorded.
Grading will be done for all using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5
Measured: Baseline , week 1 , week 2 , week 3 , week 4 , week 5 ,week 6 , conclusion of RT
Quality of life indices
Objective scoring with European Organisation For Research And Treatment Of Cancer(EORTC) Quality of Life Questionnaire(QLQC-30), brain specific module (BN 20)
Measured: will be done at 3 months
QTWiST (Quality of life Without Symptoms or Toxicity) calculation
Objective score calculation using mean duration in each health state weighed by a utility coefficient; from QLQC 30- BN 20 scores and the time spent in serious toxicity and without relapse.
Measured: will be done at 3 months
Any treatment emergent late toxicity recording
All treatment emergent late toxicity- expected and unexpected, will be recorded after completion of chemotherapy. Grading will be done for all using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
Measured: After completion of 6 cycles of adjuvant chemotherapy, at 3months, 6months, 9months and 12months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Jan 2025
- Primary completion8 Nov 2028 (estimated)
- Study completion8 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Chatterjee, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720727
- Sponsor's protocol ID
- 4481
- Acronym
- CHARM
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniospinal Irradiation in Histone AlteRed Midline Glioma (CHARM) - A Phase II Open Label Prospective Study
- ClinicalTrials.gov ID
- NCT06720727
- Acronym / sponsor ID
- CHARM / 4481
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 8 Nov 2028 (estimated)
- Study completion
- 8 Nov 2028 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Paediatric H3K27/H3G34 mutant diffuse midline gliomas (DMGs) are aggressive high-grade gliomas predominantly affecting midline structures and cerebral hemispheres. Despite aggressive therapy including radiation and chemotherapy, these tumors carry a poor prognosis, particularly in children, with frequent recurrence and high risk of leptomeningeal spread. Current standard treatment involves definitive radiation therapy to the primary site and concurrent temozolomide chemotherapy following histological confirmation via biopsy. However, outcomes remain suboptimal, prompting exploration of more intensive therapeutic strategies.
Primary objective:
To study if the addition of craniospinal irradiation to standard practice improves outcomes in pediatric diffuse midline glioma.
Secondary objectives:
- Estimate median time to leptomeningeal dissemination and compare with historical control
- Study patterns of failure
- Early and late toxicities
- Study quality of life indices
- To estimate QTWiST (Quality of life without symptoms or toxicity)
Primary endpoint: Overall survival at 12 months
Secondary endpoints:
- 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.
Study setting: The study will be conducted in the department of Radiation Oncology, Neuro Oncology Disease management group
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: craniospinal irradiationCraniospinal 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| craniospinal irradiationDelivering radiotherapy to brain, spinal cord and its covering membrane. | Radiation | Single arm |
Primary outcome
Survival Outcomes
Time frame: at 12 months
Overall survival- time in months between the date of diagnosis to date of death due to any cause
6 secondary outcomes
Leptomeningeal Dissemination
Time frame: at 12 months
Patterns of failure
Time frame: at 12 months
Any treatment emergent acute toxicity recording
Time frame: Baseline , week 1 , week 2 , week 3 , week 4 , week 5 ,week 6 , conclusion of RT
Quality of life indices
Time frame: will be done at 3 months
QTWiST (Quality of life Without Symptoms or Toxicity) calculation
Time frame: will be done at 3 months
Any treatment emergent late toxicity recording
Time frame: After completion of 6 cycles of adjuvant chemotherapy, at 3months, 6months, 9months and 12months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhishek Chatterjee, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing craniospinal irradiation in people with Glioma, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhishek Chatterjee, MD (2224177000 ext. 6015, chatterji08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Outcomes (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.