RecruitingNot ApplicableNCT07338526

Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)

Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial

Sponsor

Tata Memorial Centre

Enrollment

94 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Brain Tumor, Pediatric

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. What is the goal of the study? 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 How will the study work? * Who can join? Children aged 6 to 16 years diagnosed with certain types of benign or low-grade brain tumors. * How are patients treated? Patients will be randomly assigned to receive either IMRT or IMPT. * What is analysed? Doctors will track survival, tumor control, cognitive function, endocrine health, and quality of life over time. * How long will it take? The study will last 10 years (5 years to enroll patients, 5 years to follow up). Proton therapy is more expensive and not widely available, so strong scientific evidence is needed to justify its use in routine treatment. If IMPT significantly improves quality of life and survival, it could become the preferred treatment, shaping future policies and making proton therapy more accessible for children who need it.

Eligibility

Min Age: 6 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a type of radiation therapy called intensity modulated proton therapy (IMPT) with standard photon radiation in children with brain tumours. Proton therapy is thought to cause less damage to healthy brain tissue, which matters greatly for a child's developing brain. **You may be eligible if...** - Your child is aged 6 to 16 years - They have been diagnosed with a primary brain tumour expected to have a good long-term outlook (e.g., low-grade glioma, meningioma, craniopharyngioma, ependymoma) - They are planned to receive focused radiation to the brain (not whole-brain radiation) - They are well enough to participate (Karnofsky/Lansky score ≥ 60) **You may NOT be eligible if...** - The tumour has spread to multiple areas of the brain or spine - Whole-brain or craniospinal radiation is planned - The radiation is for palliative (comfort) purposes only - They have received radiation to this area before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity-modulated proton therapy (IMPT)

Patients in the experimental arm will receive focal cranial radiotherapy using proton therapy delivered with IMPT or proton arc techniques. Dose prescriptions and volumes will match institutional standards independent of study allocation. Planning will include CT and MRI fusion, with target and OAR delineation identical to the control arm. Proton plans will use robust optimization and undergo multidisciplinary review. Treatment will be delivered with image guidance, with weekly toxicity monitoring and standard clinical and imaging follow-up.

RADIATIONPhoton-based intensity-modulated radiation therapy (IMRT).

Patients in the control arm will receive focal cranial radiotherapy using photon-based IG-IMRT delivered with VMAT. Dose, fractionation, and target volumes will follow standard institutional protocols based on tumor type and molecular features. Planning CT and MRI fusion will guide contouring of GTV, CTV, PTV, and organs at risk. Treatment plans will be generated in the Treatment Planning System and reviewed in multidisciplinary meetings. Radiotherapy will be delivered on IGRT-equipped linear accelerators, with weekly assessments for acute toxicities and routine follow-up imaging as per standard care.