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CTRI Number  CTRI/2024/11/076832 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing conventional radiotherapy vs stereotactic radiotherapy in GBM 
Scientific Title of Study   A phase II randomized controlled study comparing post-operative stereotactic radiotherapy versus conventional radiotherapy along with concurrent and adjuvant temozolomide in patients with de novo glioblastoma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali V R 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 143-b, First floor Department of Radiation Oncology Dr.B.R.A.IRCH AIIMS

South
DELHI
110029
India 
Phone  9446948374  
Fax    
Email  dr.anjali.v.ramdulari@gmail.coM  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali V R 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 143-b, First floor Department of Radiation Oncology Dr.B.R.A.IRCH AIIMS

South
DELHI
110029
India 
Phone  9446948374  
Fax    
Email  dr.anjali.v.ramdulari@gmail.coM  
 
Details of Contact Person
Public Query  
Name  Dr Anjali V R 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 143-b, First floor Department of Radiation Oncology Dr.B.R.A.IRCH AIIMS

South
DELHI
110029
India 
Phone  9446948374  
Fax    
Email  dr.anjali.v.ramdulari@gmail.coM  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Ansari Nagar East New Delhi India 110029 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  AIIMS Ansari Nagar New Delhi 110029  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Anjali V R  AIIMS, NEW DELHI  ROOM 143B FIRST FLOOR RT WARD, DEPARTMENT OF RADIATION ONCOLOGY, DR BRAIRCH, AIIMS NEW DELHI
South
DELHI 		 9446948374

dr.anjali.v.ramdulari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (2) ICD-10 Condition: C714||Malignant neoplasm of occipital lobe, (3) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (4) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (5) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional fractionated external beam radiotherapy 60Gy in 30 fractions over 6 weeks with adjuvant and concurrent temozolomide  Conventional fractionated external beam radiotherapy 60Gy in 30 fractions over 6 weeks (5 days a week) with concurrent ( 75mg/m2) and adjuvant temozolomide ( 150-200 mg/m2 ) for 6 cycles 
Intervention  Hypo fractionated stereotactic external beam radiotherapy 42Gy in 6 fractions with concurrent and adjuvant temozolomide  Hypo fractionated stereotactic external beam radiotherapy 42Gy in 6 fractions, alternate days over 2 weeks with concurrent ( 75mg/m2) and adjuvant temozolomide ( 150-200 mg/m2 ) for 6 cycles 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with histopathological
confirmed diagnosis of GBM

Eastern Cooperative Oncology Group
(ECOG) performance status (PS) 0-2

Absence of uncontrolled medical
comorbidity

Normal organ function (Hb;10 g/dL,
platelet count >;1 lakh/cu mm,
creatinine clearance > 60 mL/sec,
AST/ALT ≤ 3 times the upper limit of
the normal range, serum bilirubin ≤
upper limit of the normal range) 
 
ExclusionCriteria 
Details  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3-4

Recurrent GBM

Any previous history of cancer treatment including surgery, radiation, or chemotherapy

Psychiatric condition or neurological co-morbidities with major cognitive function disorder

Any uncontrolled comorbidity that may compromise the delivery of protocol-defined chemotherapy and radiotherapy e.g., renal disease, cardio-respiratory disease, diabetes mellitus

Contraindications for CT/MRI imaging or contrast injection
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess and compare the median
overall survival between the experimental and conventional arm at 1 year 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the incidence
of grade 2 or worse acute toxicity
profile in the 2 arms 		 Weekly during radiotherapy and at 1 and 3 months 
To assess the treatment response
rate after treatment completion in two
arms. 		 3 and 6 months post treatment completion 
To compare the progression-free
survival in the 2 arms. 		 1 year 
To compare the quality of life in the
two arms 		 Baseline, 1, 3 and 6 months post treatment completion 
To assess and compare the caregiver
burden related to patients 		 Baseline, 1 and 3 months post treatment completion 
To assess and compare the impact
on cognition in two treatment arms. 		 3 and 6 months post treatment completion 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/12/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Glioblastoma is one of the most aggressive malignancies of the central nervous system with a median survival of only 14.6 months even after standard-of-care treatment, which is maximal safe resection followed by adjuvant radiotherapy with concurrent and adjuvant temozolomide. A dose of 60Gy in
30 fractions delivered over 6 weeks is the conventional standard dose regimen for adjuvant radiotherapy in glioblastoma The most common pattern of recurrence is local relapse and almost 85-90% of relapses occur in the radiation field or high-dose areas, suggesting a role for dose escalation. 

Stereotactic radiotherapy, if found effective and safe would provide a novel method to escalate the dose delivered to the post-op bed with better sparing of surrounding critical structures. SRT also reduces the overall treatment time which might lead to better local control and decrease the patient load in high-volume centers.  The present study has been designed to assess the survival and toxicity profile of  hypo fractionated stereotactic radiotherapy
 
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