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CTRI Number  CTRI/2025/01/079080 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of 2 different Radiotherapy Schedules in Glioblastoma Multiforme patients 
Scientific Title of Study   Hypofractionated accelerated Radiotherapy versus Conventional Radiotherapy in Glioblastoma Multiforme: A prospective randomised controlled study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipanjan Nandi  
Designation  Junior Resident  
Affiliation  Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi  
Address  Department of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh -221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8240816602  
Fax    
Email  sknandin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sunil Choudhary  
Designation  Professor  
Affiliation  Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi  
Address  Department of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh -221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  9559481453  
Fax    
Email  drsunil104@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dipanjan Nandi  
Designation  Junior Resident  
Affiliation  Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi  
Address  Department of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh -221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  8240816602  
Fax    
Email  sknandin@gmail.com  
 
Source of Monetary or Material Support  
Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi, Uttar Pradesh, India -221005 
 
Primary Sponsor  
Name  Department of Radiotherapy and Radiation Medicine Institute of Medical Sciences BHU 
Address  Departmemt of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.-221005, India 
Type of Sponsor  Government medical college 
 
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 DIPANJAN NANDI  Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, U.P.  Departmemt of Radiotherapy and Radiation Medicine, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P.-221005
Varanasi
UTTAR PRADESH 		 8240816602

sknandin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional chemo radiation, adjuvant chemotherapy   60 Grey delivered in 30 fractions, once daily over 40 days with concurrent Temozolomide @ 75 mg/m2 once daily and six cycles of adjuvant Temozolomide @ 150-200 mg/m2 starting 4 weeks after Radiotherapy, once daily for 5 days and each cycle administered at an interval of 4 weeks 
Intervention  Hypofractionated accelerated chemo radiation , adjuvant chemotherapy   52.5 Grey delivered in 15 fractions, once daily over 19 days with concurrent Temozolomide @ 75 mg/m2 once daily and six cycles of adjuvant Temozolomide @ 150-200 mg/m2 starting 4 weeks after Radiotherapy, once daily for 5 days and each cycle administered at an interval of 4 weeks. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Histologically proven patients of Glioblastoma Multiforme
2. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
3. Patients willing to give written consent for the study. 
 
ExclusionCriteria 
Details  1. Recurrent cases of Glioblastoma Multiforme, previously treated.
2. Patients with any contraindications to Radiotherapy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Loco regional control  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival
Progression free survival
Quality of Life 		 2 years 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   30/01/2025 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sknandin@gmail.com].

  6. For how long will this data be available start date provided 03-01-2027 and end date provided 03-01-2037?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a prospective, open label randomised controlled study comparing the safety and efficacy of Hypofractionated accelerated Radiotherapy at 52.5 Grey in 15 fractions with Conventional Radiotherapy at 60 Grey in 30 fractions, both administered with concurrent temozolomide @ 75 mg/m2 once daily throughout radiotherapy and six cycles of adjuvant temozolomide @ 150-200 mg/m2 starting 4 weeks after Radiotherapy, administered once daily for 5 days and each cycle delivered at an interval of 4 weeks in 52 patients of Glioblastoma Multiforme. The study is single institutional which aims to assess loco-regional control as primary outcome and overall survival, progression free survival and Quality of life as secondary oiutcomes. 
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