| 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
|
|
|
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
|
|
|
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. |