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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  
Name  Address 
NA  NIL 
 
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  
Status 
Not Applicable 
 
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.  

 
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