| CTRI Number |
CTRI/2024/10/075589 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Radiotherapy in Glioma with Development of Artificial Intelligence |
|
Scientific Title of Study
|
Glioma Adaptive Radiotherapy with Development of an Artificial Intelligence Workflow- (GLADIATOR) |
| Trial Acronym |
GLADIATOR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archya Dasgupta |
| Designation |
Assistant Professor,Radiation Oncology |
| Affiliation |
Tata Memorial Centre,Mumbai |
| 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 |
| Phone |
0224176020 |
| Fax |
|
| Email |
archya1010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Archya Dasgupta |
| Designation |
Assistant Professor,Radiation Oncology |
| Affiliation |
Tata Memorial Centre,Mumbai |
| Address |
Department of Radiation Oncology
Neuro-oncology Disease Management Group
Room number 1002
Homi Bhabha Building
Tata Memorial Centre
Mumbai
MAHARASHTRA
India
MAHARASHTRA 400012 India |
| Phone |
0224176020 |
| Fax |
|
| Email |
archya1010@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Archya Dasgupta |
| Designation |
Assistant Professor,Radiation Oncology |
| Affiliation |
Tata Memorial Centre,Mumbai |
| Address |
Department of Radiation Oncology
Neuro-oncology Disease Management Group
Room number 1002
Homi Bhabha Building
Tata Memorial Centre
Mumbai
MAHARASHTRA
India
MAHARASHTRA 400012 India |
| Phone |
0224176020 |
| Fax |
|
| Email |
archya1010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Homi Babha Building, Dr Ernest Borges Rd, Parel East, Mumbai, Maharashtra, India 400012 |
|
|
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 Archya Dasgupta |
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 |
0224176020
archya1010@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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Radiotherapy |
Adaptive radiotherapy will be delivered based on interval imaging using MRI and PET. Fractionated radiotherapy will continue on daily basis, 5 days a week, for a duration of 6-7 weeks. Imaging with PET will be done twice during treatment and MRI will be done once weekly during treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Histological diagnosis of diffuse glioma. Patients with IDH-negative GBM (stratum A) and IDH-mutant
glioma (astrocytoma or oligodendroglioma) needing radiotherapy (stratum B).
2. Age: 18-70 years.
3.Karnofsky Performance Scale (KPS) ≥60 |
|
| ExclusionCriteria |
| Details |
Multifocal or multicentric disease
• Not eligible for radical intent radiation.
• IDH status unknown or uninterpretable (IHC or gene sequencing).
• Use of prior radiotherapy to the head-neck region or brain or chemotherapy.
• Contraindication/unable to undergo MRI or PET scan during radiation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients undergoing volumetric and biological adaptation.
• Cumulative rate of symptomatic radionecrosis (RN) at 2 years. |
Cumulative rate of symptomatic radionecrosis (RN) at 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression free survival,Overall survival |
4 years |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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)
Modification(s)
|
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
|
Patients with brain tumors may experience sudden bursts of uncontrolled electrical activities in their brain, which is medically termed a seizure. In routine medical practice, doctors prescribe medications to prevent the consequences of seizures and avoid the occurrence of seizure events. Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes. The study will be conducted at Tata Memorial Centre with a population of 604 patients for a duration of seven years. |