Proton Beam Therapy in children: A Phase 3 Randomized Controlled Trial

Intensity Modulated Proton therapy in pediatric brain Tumors: A Phase 3 Randomized Controlled Trial - IMPORT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098245

Enrollment

186

Registered

2025-12-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D496- Neoplasm of unspecified behavior of brain

Interventions

Intervention1: 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, endocri

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Re-irradiation Palliative radiotherapy Multifocal or multicentric disease Planned for whole brain irradiation or craniospinal irradiation Planned for hypo-fractionated or stereotactic radiotherapy

Design outcomes

Primary

Measure	Time frame
Qualified Overall Survival (qOS)Timepoint: 5 years	—

Secondary

Measure	Time frame
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 survivalTimepoint: At the end of study completion;6) Cost Effectiveness (EQ5D5L)Timepoint: At baseline;7) Quality of life (patient reported outcomes)Timepoint: At baseline, RT conclusion, & then at 6 monthly follow up	—

Measure

Time frame

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 survivalTimepoint: At the end of study completion;6) Cost Effectiveness (EQ5D5L)Timepoint: At baseline;7) Quality of life (patient reported outcomes)Timepoint: At baseline, RT conclusion, & then at 6 monthly follow up

—

Countries

India

Contacts

Public ContactDr Abhishek Chatterjee

Tata Memorial Centre

chatterji08@gmail.com0224176015

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026