| CTRI Number |
CTRI/2025/12/098245 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Proton Beam Therapy in children: A Phase 3 Randomized Controlled Trial |
Scientific Title of Study
Modification(s)
|
Intensity Modulated Proton therapy in pediatric brain Tumors: A Phase 3 Randomized Controlled Trial |
| Trial Acronym |
IMPORT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
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 400012 India
Mumbai
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 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 400012 India
MAHARASHTRA
400012
India |
| Phone |
0224176015 |
| Fax |
|
| Email |
chatterji08@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMH Intramural Funding Support |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Radiation Oncology Tata Memorial Hospital, 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 Abhishek Chatterjee |
Tata Memorial Centre |
Homi Bhabha Building
Ground floor,
Room number 056
Mumbai
MAHARASHTRA |
224176015
chatterji08@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Photon Therapy |
Despite advancements in high precision RT delivery
such as Intensity-Modulated Radiation Therapy (IMRT), modern photon-based RT inevitably exposes large
volumes of normal brain tissue to lower doses of radiation, which disrupts white matter integrity and
causes neuroinflammation, microvascular damage, and neurotoxicity, carrying a significant risk for a
plethora of late effects such as cognitive impairment, hormonal dysfunction, audio-visual defects,
cerebrovascular accidents, and secondary malignancies. |
| Intervention |
Proton Therapy |
Proton beam therapy offers clear dosimetric advantages over photon therapy in terms of sparing normal
tissues at risk of debilitating late toxicities (cognitive, endocrine, vascular, second primary neoplasms) in
benign and low-grade tumors and therefore, has the potential to improve both quantity and quality of life. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Age at irradiation: 6 to 16 years
Karnofsky/ Lansky Play Performance Status more than equal to 60
Diagnosis (histopathological/ radiological) of primary brain tumor with an expected survival of more than 5 years
(e.g., circumscribed gliomas, low grade gliomas, low-grade glial/ glioneuronal tumors, meningioma,
pituitary tumors, schwannoma, craniopharyngioma, ependymoma)
Planned for focal cranial radiotherapy
Informed consent taken
|
|
| ExclusionCriteria |
| Details |
Re-irradiation
Palliative radiotherapy
Multifocal or multicentric disease
Planned for whole brain irradiation or craniospinal irradiation
Planned for hypo-fractionated or stereotactic radiotherapy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Qualified Overall Survival (qOS) |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Response Rate (complete & partial response) as decided by contemporary image-based response criteria (RAPNO, RANO-LGG 2.0)
2) Overall survival (defined as the time elapsed between date of randomisation to death due to any cause)
3) Progression-free survival (defined as the time elapsed between date of randomisation to documented clinico-radiological progression or death)
4) Post hoc analysis per stratification factors
5) Cumulative incidence of sub-domains of qualified overall survival |
At the end of study completion |
| 6) Cost Effectiveness (EQ5D5L) |
At baseline |
| 7) Quality of life (patient reported outcomes) |
At baseline, RT conclusion, & then at 6 monthly follow up |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
08/12/2025 |
| 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="10"
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
|
Children diagnosed with
benign or low-grade brain tumors often require radiation therapy to control
their disease. While radiation can be effective, traditional techniques using
X-rays (photon-based radiotherapy) expose healthy brain tissue to radiation, potentially
leading to long-term side effects like memory loss, learning difficulties,
hormone imbalances, hearing problems, and a higher risk of secondary cancers.
This study, called the IMPORT Trial, aims to compare two types of radiation
therapy—Intensity-Modulated Proton Therapy (IMPT) and Intensity-Modulated
Radiation Therapy (IMRT)—to determine which is safer and more effective for
children. IMPT, a newer technique, uses protons instead of X-rays to deliver
radiation, reducing exposure to healthy brain tissue. Researchers believe this
could help minimize long-term damage while maintaining effective tumor control. The primary goal is to see
if IMPT leads to better survival with fewer side effects compared to IMRT. The
study will track how well children function over five years, looking at:
- Cognitive abilities (memory, attention,
learning)
- Hormonal balance (pituitary gland
function)
- Hearing ability
- Overall survival without significant
decline in quality of life
- The study will last 10 years (5 years to
enroll patients, 5 years to follow up).
Children aged 6 to 16 years diagnosed with certain types of benign or low-grade tumours (e.g., circumscribed gliomas, low grade gliomas, low-grade glial/ glioneuronal tumors, meningioma,
pituitary tumors, schwannoma, craniopharyngioma, ependymoma) will be enrolled in the study. Patients will be randomly assigned to either IMRT or IMPT. Doctors will track survival, tumor control, cognitive
function, endocrine health, and quality of life over time. |