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CTRI Number  CTRI/2025/09/095181 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing cognitive outcome in two different techniques of brain irradiation in patients of brain metastasis from breast cancer 
Scientific Title of Study   A prospective randomized study to compare Whole Brain Radiotherapy versus Stereotactic Radiosurgery or Stereotactic Radiotherapy in patients with brain metastasis from breast cancer. 
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 Shubham Jangle 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh 
Address  Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of Medical Education and Research(PGIMER),Sector 12,Chandigarh
PGIMER
Chandigarh
CHANDIGARH
160012
India 
Phone  8412997776  
Fax    
Email  shubhamjangle1654@gamil.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Budhi Singh Yadav 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh 
Address  Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of Medical Education and Research(PGIMER),Sector 12,Chandigarh
PGIMER
Chandigarh
CHANDIGARH
160012
India 
Phone  9815981176  
Fax    
Email  drbudhi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Budhi Singh Yadav 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh 
Address  Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of Medical Education and Research(PGIMER),Sector 12,Chandigarh
PGIMER
Chandigarh
CHANDIGARH
160012
India 
Phone  9815981176  
Fax    
Email  drbudhi@gmail.com  
 
Source of Monetary or Material Support  
Department of Radiotherapy and Clinical Oncology, Room no 54, Nehru Hospital Extension Block, Postgraduate Institute of Medical Education and Research(PGIMER), Sector 12, Chandigarh 
 
Primary Sponsor  
Name  Department of Radiotherapy and Clinical Oncology, PGIMER, Chandigarh 
Address  Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh 
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 Shubham Jangle  Postgraduate Institute of Medical Education and Research(PGIMER), Chandigarh  Room no. 54, Ground floor, Nehru hospital extension block, Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of Medical Education and Research(PGIMER), Sector 12, Chandigarh, PIN code-160012
Chandigarh
CHANDIGARH 		 8412997776

shubhamjangle1654@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research(PGIMER), Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Stereotactic radiosurgery or stereotactic radiotherapy  One group will receive radiotherapy of cranial irradiation by highly conformal localised brain radiotherapy 
Comparator Agent  Whole Brain Radiotherapy   One group will receive radiotherapy of cranial radiation by whole brain radiotherapy technique with hippocampal avoidance  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Biopsy proven case of breast cancer.
Those who are willing to give written informed consent.
1 to 5 brain lesions with maximum diameter less than 3.5cm for each lesion
KPS score more than 70 
 
ExclusionCriteria 
Details  Age less than 18 years
KPS less than 70
Any non malignant known CNS disease that can cause neurocognitive dysfunction
Number of lesion more than 5 or any lesion with size more than 3.5cm 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare cognitive outcome between two arms  At baseline, 3 months, 6 months, 12 months after completion of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Quality of life assessment, Overall survival, Toxicity profile between two arms  At baseline, 3 months, 6 months, 12 months after completion of treatment 
 
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 4 
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="1"
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   Management of brain metastasis with primary from breast cancer is usually brain irradiation. In this study patients with less than 5 brain metastasis will receive radiation either by whole brain radiotherapy or by stereotactic radiotherapy techniques by randomizing patients in two arms. We aims to asses neurocognitive outcome and quality of life in both the arms. 
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