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CTRI Number  CTRI/2025/09/094953 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of Response and Dosimetry between different Radiotherapy schedules in High Grade Glioma 
Scientific Title of Study   Comparison of Response and Dosimetry between Sequential Boost and Simultaneous Integrated Boost (with two different dose schedules) in Radiotherapy for High Grade Gliomas 
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 Shatarupa Chattopadhyay 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  R G Kar Medical College and Hospital, Kolkata 
Address  Department of Radiation Oncolobgy,
R G Kar Medical College, 1 Kshudiram Bose Sarani
Kolkata
WEST BENGAL
700004
India 
Phone  8910383179  
Fax    
Email  drshatarupadutta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shatarupa Chattopadhyay 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  R G Kar Medical College and Hospital, Kolkata 
Address  Department of Radiation Oncology
R G Kar Medical College, 1 Kshudiram Bose Sarani
Kolkata
WEST BENGAL
700004
India 
Phone  8910383179  
Fax    
Email  drshatarupadutta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shatarupa Chattopadhyay 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  R G Kar Medical College and Hospital, Kolkata 
Address  Department of Radiation Oncology
R G Kar Medical College, 1 Kshudiram Bose Sarani
Kolkata
WEST BENGAL
700004
India 
Phone  8910383179  
Fax    
Email  drshatarupadutta@gmail.com  
 
Source of Monetary or Material Support  
R G Kar Medical College, 1 Kshudiram Bose Sarani, Kolkata West Bengal 700004 
 
Primary Sponsor  
Name  Dr Shatarupa Chattopadhyay Dutta 
Address  1 Kshudiram Bose Sarani, Kolkata 700004 
Type of Sponsor  Other [Self] 
 
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 Sandhya Narzary  R G Kar Medical College  Department of Radiation Oncology, R G Kar Medical College, 1 Kshudiram Bose Sarani, Kolkata, West Bengal 700004
Kolkata
WEST BENGAL 
8910383179

drshatarupadutta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, R G Kar Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C71||Malignant neoplasm of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sequential Boost   Sequential Boost Radiotherapy with PTV1 46Gy/23#/5weeks followed by PTV2 Boost with 14Gy/7#/2weeks with Concurrent Temozolomide orally 75mg per m2 
Comparator Agent  Simultaneous Integrated Boost 1  Simultaneous Integrated Boost Radiotherapy with PTV1 50Gy/25#/5weeks and PTV2 60 Gy/25#/weeks simultaneously with Concurrent Temozolomide orally 75mg per m2 
Comparator Agent  Simultaneous Integrated Boost 2  Simultaneous Integrated Boost Radiotherapy with PTV1 51Gy/30#/6weeks and PTV2 60 Gy/30#/6weeks simultaneously with Concurrent Temozolomide orally 75mg per m2 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. All patients of biopsy proven non metastatic high grade glioma
2. ECOG Performance Status 0 to 2.
3. Normal baseline hematological and biochemical parameters
4. Patients willing to provide informed consent with signature or left thumb impression for the approval for inclusion in the study.
 
 
ExclusionCriteria 
Details  1. Evidence of distant metastasis by clinical or radiographic means.
2. Prior Radiotherapy
3. History of prior malignancy.
4. Pre-existing uncontrolled co-morbid medical conditions like Diabetes mellitus, cardiac ailments, neurological ailments for which deviation from oncological treatment protocol is required.
5. Patient refusal to undergo radiation.
6. Pregnancy or Lactation.
7. Other synchronous or metachronous primary malignancy.
8. Allergy to iodinated IV contrast or gadolinium.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare response assessment, toxicity profiles, OS, PFS, dosimetric analysis and neurocognitive function in patients receiving Sequential Boost and Simultaneous Integrated Boost Radiotherapy (with two different dose schedules) in High Grade Gliomas  24months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Phase 3 
Date of First Enrollment (India)   30/09/2025 
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="2"
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  

High-grade gliomas account for approximately 59% of all primary brain tumors in adults in India. They are rapidly growing tumors that directly invade the brain parenchyma but almost never metastasize outside the CNS. They present in any age group, although most occur in late adulthood. GBM accounts for approximately 75% of all high-grade gliomas. Treatment for high grade gliomas involve a multidisciplinary approach which include neurosurgeons, radiation oncologists, physicists and medical oncologists. However, high grade gliomas carry poor prognosis with standard treatments, due to the nature of disease and its close proximity to vital structure in the central nervous system.

This will be a single institutional, prospective, interventional study. Eligible patients

of high grade gliomas will undergo proper clinical examination, laboratory

and imaging investigations. Three simultaneous radiation treatment plans will be generated, one of Sequential Boost and two of Simultaneous Integrated Boost RT. At the end of treatment planning, all the plans would be compared in terms of Planning Total Volume coverage, sparing of Organs At Risk, Homogeneity Index and Conformity Index. Patients would be followed up for response assessment, toxicity profiles, OS, PFS, and neurocognitive function.

 


 
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