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CTRI Number  CTRI/2025/03/082568 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare Proton and Photon Radiotherapy in Adults with Primary Brain Tumors 
Scientific Title of Study   Proton versus Photon Radiotherapy In Adults with primary brain tumors Evaluating functional survival A Phase 3 Randomized Controlled Trial 
Trial Acronym  PRIDE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ARCHYA DASGUPTA 
Designation  Associate Professor Radiation Oncology  
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block Neuro Oncology DMG OPD No 70

Mumbai
MAHARASHTRA
400012
India 
Phone  022241760176020  
Fax    
Email  archya1010@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ARCHYA DASGUPTA 
Designation  Associate Professor Radiation Oncology  
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block Neuro Oncology DMG OPD No 70

Mumbai
MAHARASHTRA
400012
India 
Phone  022241760176020  
Fax    
Email  archya1010@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ARCHYA DASGUPTA 
Designation  Associate Professor Radiation Oncology  
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block Neuro Oncology DMG OPD No 70

Mumbai
MAHARASHTRA
400012
India 
Phone  022241760176020  
Fax    
Email  archya1010@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai- 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road Tata Memorial Hospital Parel Mumbai Maharashtra 400012 
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 Archya Dasgupta  Tata Memorial Centre  Homi Bhabha Block, Dr E Borges Road Neuro Oncology DMG OPD No 70
Mumbai
MAHARASHTRA 
02224176017

archya1010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, (2) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  photon therapy  Proton beam therapy (experimental arm) is superior in functional preservation compared to photon therapy (standard arm) in adults with primary brain tumors receiving focal radiotherapy with conventional fractionation- 6 weeks 
Comparator Agent  Proton   Proton beam therapy (experimental arm) is superior in functional preservation compared to photon therapy (standard arm) in adults with primary brain tumors receiving focal radiotherapy with conventional fractionation.- 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Primary brain tumors
2. Age at irradiation 18 to 70 years
3. Karnofsky Performance Status more than 60
4. Diagnosis histopathological radiological of primary brain tumor with an expected survival of above 5 years
5. Planned for focal cranial radiotherapy
6. Informed consent taken
 
 
ExclusionCriteria 
Details  1. Reirradiation
2. Palliative radiotherapy
3. Multifocal or multicentric disease
4. Planned for whole brain irradiation or craniospinal irradiation
5. Planned for hypofractionated or stereotactic radiotherapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary endpoint
The 5 year rate of overall survival without functional deterioration functional survival equal to fS will be
calculated from the date of randomization. An event concerning the primary endpoint will include

Neurocognitive decline
CTCAE grade 2 ototoxicity
New neuroendocrine axis dysfunction or worsening of pre existing dysfunction
Neurological and functional impairment
CTCAE gr 3 radionecrosis
Disease progression
All cause mortality 
5 years  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoints:
1. Overall survival & Progression-free survival.
2. Radiation-induced early toxicity.
3. Cumulative incidence of sub-domains of functional survival.
4. Quality of Life (patient-reported outcomes)
5. Post hoc analysis per stratification factors 
At the completion of the study 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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)   01/04/2025 
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="7"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This study will be done in adults with brain tumors having good life expectancy requiring treatment with radiotherapy. The current practice for brain radiotherapy involves an advanced technique of radiation using X rays (photon radiotherapy). Another newer technology for delivering radiation is available called proton beam therapy, which allows to reduce the lower dose of radiation to the parts pf brain surrounding the tumor. After treatment with photon radiotherapy certain late effects of radiation like memory decline, hormonal deficits, hearing loss, worsening of neurological function can occur in some patients. From evaluation of dose profiling, proton beam therapy has potential to reduce the possibility of side effects by reducing dose to critical organs. However, there is no clinical data to demonstrate whetherthe theoretical dose reduction translates to a clinically meaningful benefit. In the proposed study, 156 patients will be randomly allocated to either proton or photon radiotherapy in 1: 1 ratio. The primary objective of the study is to explore whether proton therapy improves functional survival which is life expectancy without recurrence, death or complications from radiotherapy.

 
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