| CTRI Number |
CTRI/2024/11/076687 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying Radiation Treatment for Brain Tumors with Midline Brain Tumors: A Phase II Trial |
|
Scientific Title of Study
|
Craniospinal irradiation in Histone AlteRed Midline glioma (CHARM) – A Phase II Open label prospective study |
| Trial Acronym |
CHARM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Chatterjee |
| Designation |
Professor,Radiation Oncology |
| Affiliation |
|
| Address |
Department of Radiation Oncology Neuro-oncology Disease Management Group Room number 1002 Homi Bhabha Building Tata Memorial Centre Mumbai MAHARASHTRA India
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
0224176015 |
| Fax |
|
| Email |
chatterji08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Chatterjee |
| Designation |
Professor,Radiation Oncology |
| Affiliation |
|
| Address |
Department of Radiation Oncology Neuro-oncology Disease Management Group Room number 1002 Homi Bhabha Building Tata Memorial Centre Mumbai MAHARASHTRA India
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
0224176015 |
| Fax |
|
| Email |
chatterji08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Chatterjee |
| Designation |
Professor,Radiation Oncology |
| Affiliation |
|
| Address |
Department of Radiation Oncology Neuro-oncology Disease Management Group Room number 1002 Homi Bhabha Building Tata Memorial Centre Mumbai MAHARASHTRA India
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
0224176015 |
| Fax |
|
| Email |
chatterji08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Chatterjee |
Tata Memorial Centre |
Department of radiation oncology, Neuro-oncology DMG, OPD no. 56, Homi Bhabha Building, ground floor, Tata Memorial Hospital. Mumbai- 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
0224176020
chatterji08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Institutional Ethics Committee-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C729||Malignant neoplasm of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Craniospinal Irradiation |
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.
Craniospinal irradiation is indicated for tumors that have a potential for spreading along the central nervous system, often when theres a risk of microscopic disease in the craniospinal axis.
- 33 fractions will be given |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
at 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
subsequent follow-up visits at 3, 6, 9 and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 we 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. |