| CTRI Number |
CTRI/2025/11/097548 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative outcomes of proton vs photon radiation therapy |
|
Scientific Title of Study
|
Protons Versus Photons In Craniospinal Axis Irradiation (Picasso): A Phase 3 Randomized Controlled Trial |
| Trial Acronym |
PICASSO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital,
Homi Bhabha Block,
Ground Floor OPD 056,
Parel,
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital,
Homi Bhabha Block,
Ground Floor OPD 056,
Parel,
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital,
Homi Bhabha Block,
Ground Floor OPD 056,
Parel,
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr E Borges Marg Parel, Mumbai -400012 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road, Parel Mumbai- 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 Tejpal Gupta |
Tata Memorial Hospital |
Dr E Borges Road, Homi Bhabha Block, Ground floor, OPD 056, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
02224177000
tejpalgupta@rediffmail.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: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Photon based radiotherapy |
Patients in the control arm (photon-based RT) will receive CSI plus TB boost using 6MV photons on a modern linear accelerator using IMRT/VMAT technique with daily image-guidance. |
| Intervention |
Proton beam therapy |
Patients in the test arm (proton beam therapy) will receive CSI plus TB boost to appropriate cobalt gray dose equivalent (CGE) on a modern proton gantry using image-guided pencil beam scanning technology or intensity modulated proton therapy (IMPT)
Total duration- 33days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of primary CNS tumor planned for craniospinal irradiation.
Curative-intent CSI with or without systemic chemotherapy.
Age at irradiation: more than 5 years to 39 years.
Fair performance status (LPS/KPS): greater equal to 60.
Written informed consent/assent. |
|
| ExclusionCriteria |
| Details |
Reirradiation
Palliative intent radiation
On concurrent medications likely to impact neurocognitive outcomes
Inability to undergo neurocognitive evaluation pre-radiation. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 2-year Qualified Overall Survival (QOS) |
2 yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
5-year progression-free survival (PFS)
5-year overall survival (OS)
5-year QOS |
5 years |
Neuro-cognitive outcome: FSIQ, Verbal comprehension, Perceptual Reasoning
Neuro-endocrine outcomes: Hormonal profile
Visual outcomes: Drop in acuity or new-onset field defects
Hearing outcomes: Chang-Brock scale
Symptomatic radiation necrosis (requiring bevacizumab)
Patterns of failure/relapse
Vasculopathy including cerebrovascular accidents (CVA)
Second malignant neoplasm (SMN) |
Baseline,6 months post RT,1yr,2yr,3yr,4yr,5yr |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
28/11/2025 |
| 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 Yet Recruiting |
| 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
|
Children and young adults with certain brain tumors often require a type of radiotherapy called craniospinal irradiation (CSI), which treats the entire brain and spine. While this treatment can help cure the disease, it often causes serious long-term side effects such as learning difficulties, hormonal problems, hearing loss, and stroke. These side effects are particularly concerning in younger patients, as they can affect their growth, schooling, and overall quality of life. This study aims to compare two types of radiation: traditional photon-based radiotherapy and a newer technique called proton beam therapy. Proton therapy can target tumors more precisely and reduce radiation to healthy tissues, which may help lower side effects. Although earlier studies suggest that proton therapy may improve outcomes like memory, learning ability, and hormone balance, no large, high-quality trials have confirmed these benefits. In this randomized controlled trial, children and young adults aged 5 to 39 years with specific types of brain tumors will be assigned to receive either proton or photon CSI. The main goal is to assess whether proton therapy results in better functional outcomes, such as cognitive ability, hormone function, and hearing, without reducing survival. Patients will undergo regular checkups, imaging, and tests over a 2-year follow-up period. This study is being conducted at Tata Memorial Centre and will enroll participants over 5 years, with a total study duration of 7 years. The findings may help improve treatment strategies and long-term outcomes for young patients with brain tumors. |