| 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
|
|
|
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
|
|
|
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. |