Intensity‑modulated proton versus photon radiation for children with benign or low-grade brain tumors
Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT07338526 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mumbai, Maharashtra
- Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: Abhishek Chatterjee, MD
- Email: chatterji08@gmail.com
- Phone: 2224177000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.