Intensity‑modulated proton versus photon radiation for children with benign or low-grade brain tumors
Official title: Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial
Run by Tata Memorial Centre · NCT07338526 · Data updated 2026-11-12
This trial will try intensity‑modulated proton therapy (IMPT) instead of standard photon IMRT to see if children aged 6–16 with benign or low‑grade brain tumors can get the same tumor control with fewer long‑term side effects.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 16 Years |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | August 7, 2025 |
| Main results expected | July 7, 2035 |
| Study ends | July 7, 2035 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT07338526 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–16 with primary benign or low‑grade brain tumors planned for focal cranial radiotherapy, a Karnofsky/Lansky performance score ≥60, and an expected survival over 5 years.
✕Probably not a fit
Patients needing re‑irradiation, palliative treatment, whole‑brain or craniospinal irradiation, those with multifocal/multicentric disease, or those planned for hypo‑fractionated or stereotactic radiotherapy are excluded and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares intensity‑modulated proton therapy (IMPT) with photon-based intensity‑modulated radiation therapy (IMRT) for children aged 6–16 who require focal cranial radiotherapy for benign or low‑grade brain tumors. Eligible patients will receive planned focal radiotherapy with either IMPT or IMRT and be followed for tumor control and treatment-related late effects, including cognitive, endocrine, and auditory outcomes. The protocol excludes re‑irradiation, palliative treatment, multifocal disease, and patients planned for whole‑brain, craniospinal, hypo‑fractionated, or stereotactic regimens. The trial is conducted at Tata Memorial Hospital with long-term follow-up to capture late toxicities given the high expected survival in this population.
Why it matters
Potential benefit: If successful, IMPT could lower radiation exposure to healthy brain tissue and reduce long-term cognitive, endocrine, hearing problems, and secondary cancer risk while maintaining effective tumor control.
How similar studies have gone: Observational and dosimetric studies indicate proton therapy reduces dose to normal tissues and may lower late effects, but high-quality randomized pediatric comparisons demonstrating long‑term clinical benefit remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at irradiation: 6 to 16 years * Karnofsky/ Lansky Play Performance Status ≥ 60 * Diagnosis (histopathological/ radiological) of primary brain tumor with an expected survival of \>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: * Re-irradiation * Palliative radiotherapy * Multifocal or multicentric disease * Planned for whole brain irradiation or craniospinal irradiation * Planned for hypo-fractionated or stereotactic radiotherapy
Where it's running
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Tata Memorial Hospital
Mumbai, Maharashtra, India Recruiting
Study contacts
- Study coordinator: Abhishek Chatterjee, MD
- Email: chatterji08@gmail.com
- Phone: 2224177000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.