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CTRI Number  CTRI/2025/11/097775 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Other 
Public Title of Study   BIOlogically- guided Short-course HypOfractionated Radiation Therapy in poor-prognosis GBM: A Prospective Phase 2 Randomised Control Trial 
Scientific Title of Study   BIOlogically- guided Short-course HypOfractionated Radiation Therapy in poor-prognosis GBM (BIO-SHORT): A Prospective Phase 2 Randomised Control Trial 
Trial Acronym  BIO-SHORT 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Chatterjee 
Designation  Professor,Radiation Oncology 
Affiliation  Tata Memorial Centre 
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
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
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  0224176015  
Fax    
Email  chatterji08@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Chatterjee 
Designation  Professor,Radiation Oncology 
Affiliation  Tata Memorial Centre 
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
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

MAHARASHTRA
400012
India 
Phone  0224176015  
Fax    
Email  chatterji08@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Chatterjee 
Designation  Professor,Radiation Oncology 
Affiliation  Tata Memorial Centre 
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
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

MAHARASHTRA
400012
India 
Phone  0224176015  
Fax    
Email  chatterji08@gmail.com   
 
Source of Monetary or Material Support  
Tata Memorial Centre Dr E Borges Marg Parel, Mumbai -400012 India  
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai 400012  
Type of Sponsor  Other [Research institution and hospital ] 
 
Details of Secondary Sponsor  
Name  Address 
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 Abhishek Chatterjee   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 Mumbai
Mumbai (Suburban)
MAHARASHTRA 
0224176020

chatterji08@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional Ethics Committee-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Radiotherapy  The standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#). The usage of TMZ will be standard across both arms. 
Intervention  Radiotherapy  The test arms will comprise of dose escalated hypo-fractionated RT (5 fractions/10 fractions). The usage of TMZ will be standard across both arms. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with biopsy proven IDH wild type GBM or imaging defined GBM
Neurological Predictor Scale (NPS) 2-3
Unfit for surgery and referred for direct RT
Age greater tuan equal to 50 years
 
 
ExclusionCriteria 
Details  IDH mutant glioma
Histone altered glioma
Multifocal disease or Gliomatosis like appearance which necessitates whole brain RT
Disseminated disease in brain or spine
NPS = 0-1 or = 4
Karnofsky Performance Status score less than 50(Patient requires considerable assistance and frequent medical care)
Prior administration of any systemic therapy directed against glioma (eg.Temozolomide, CCNU, Bevacizumab)
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of the study is overall survival at 1 year, which will be defined as the time from randomization to death from any cause will be considered as an event.   The primary endpoint of the study is overall survival at 1 year, which will be defined as the time from randomization to death from any cause will be considered as an event.  
 
Secondary Outcome  
Outcome  TimePoints 
Progression Free Survival(PFS) at 1 year-Progression Free Survival will be defined as the time elapsed fromthe date of randomization to the date of clinico-radiological progression or death.  1 year 
Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)  At baseline, at RT conclusion 
Quality of life indices using the EORTC QLQC- 30 and its BN -20 module  At baseline. at RT conlusion and there after at 6 monthly follow up 
Quality of life without symptoms or toxicity in three health states TOX (toxicity), TWIST (time without symptoms) and REL (relapse)  At baseline. at RT conlusion and there after at 6 monthly follow up 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   07/12/2025 
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="6"
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 - NO
Brief Summary   Study Type: Prospective Phase II Randomised Controlled Trial 
Principal Investigator: Dr Abhishek Chatterjee 
Study Site: Tata Memorial Centre, Mumbai 

High grade gliomas, particularly glioblastoma, are among the most aggressive brain tumors and are associated with poor outcomes despite standard treatment. Many patients, especially older adults or those with poor general health, are not suitable for surgery and have a life expectancy of less than 12 months. Current standard includes a shortened course of radiotherapy (over 3 weeks) combined with chemotherapy using temozolomide (TMZ), which offers limited survival benefits. This study aims to explore whether delivering radiotherapy in a shorter duration (1 or 2 weeks) at a higher dose, guided by advanced imaging with a PET scan, can improve survival in this group of patients. PET scans help identify the most active parts of the tumor, which aids in targeting of these areas more precisely, potentially improving outcomes while reducing harm to healthy brain tissue. This study will randomly assign 116 eligible patients into two groups: • One group will receive the current standard of care (3-week radiotherapy + TMZ). • The other group will receive PET-guided radiotherapy over a shorter duration (either 5 or 10 sessions) at a higher dose, alongside TMZ. The primary goal is to compare overall survival at one year between the two groups. The study will also assess how the disease progresses, side effects of treatment, and the impact on patients’ quality of life. The study will be conducted over a total period of 6 years, including 4 years for patient enrolment and 2 years of follow-up. Participation in the study is entirely voluntary, and all patients will undergo an informed consent process. The study has been designed to follow all applicable ethical and regulatory guidelines. The results may help establish a more effective and convenient treatment option for patients with aggressive brain tumors and poor prognosis.
 
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