Actively Recruiting
Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial
Led by Tata Memorial Centre · Updated on 2026-01-30
94
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two types of radiation therapy in children aged 6 to 16 years with benign or low-grade brain tumors. The study evaluates whether Intensity-Modulated Proton Therapy (IMPT), a newer method using protons, is safer and more effective than the standard Intensity-Modulated Radiation Therapy (IMRT) with X-rays. It focuses on reducing long-term side effects like memory and learning difficulties, hormone problems, hearing loss, and secondary cancers, while maintaining tumor control and survival. Participants are randomly assigned to receive either IMRT using photon-based Image Guided Intensity Modulated Radiotherapy or IMPT using proton therapy with pencil beam scanning or proton arc techniques. Both treatments involve detailed planning with CT and MRI imaging and are delivered with advanced image guidance. Weekly monitoring for side effects occurs during treatment, and standard clinical and imaging follow-up is done after therapy. Treatment doses and volumes are based on tumor type and clinical standards. During the study, children will be regularly assessed over five years for survival, tumor control, cognitive abilities, endocrine function, hearing, and quality of life. Evaluations include neurocognitive testing, hormone assessments, audiology exams, and patient-reported surveys. The study will last 10 years, with 5 years of enrollment and 5 years of follow-up. Researchers aim to see if IMPT leads to better qualified overall survival by combining survival and quality of life measures, helping guide future treatment decisions for pediatric brain tumors.
CONDITIONS
Brief Title
Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at irradiation between 6 and 16 years
- Karnofsky or Lansky Play Performance Status of 60 or higher
- Diagnosis of a primary benign or low-grade brain tumor with expected survival over 5 years (including circumscribed gliomas, low grade gliomas, low-grade glial/glioneuronal tumors, meningioma, pituitary tumors, schwannoma, craniopharyngioma, ependymoma)
- Planned for focal cranial radiotherapy
- Informed consent obtained
You will not qualify if you...
- Prior brain re-irradiation
- Planned palliative radiotherapy
- Multifocal or multicentric brain disease
- Planned whole brain or craniospinal irradiation
- Planned hypo-fractionated or stereotactic radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiotherapy duration as per institutional standards (typically several weeks)
Participants receive focal cranial radiotherapy using either proton therapy with intensity-modulated proton therapy (IMPT) or photon-based intensity-modulated radiation therapy (IMRT). Treatment includes image-guided planning and weekly toxicity monitoring.
Weekly visits during radiotherapy for treatment and toxicity monitoring
Duration - Up to 5 years post-treatment
Participants undergo post-treatment monitoring including imaging, neurocognitive testing, endocrine and audiological assessments, and quality of life evaluations to assess tumor control and potential late effects.
Multiple follow-up visits at radiotherapy conclusion, 3 months, 1 year, then annually up to 5 years
Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
A
Abhishek Chatterjee, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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