NCT07338526 Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)

Eligibility & Interventions

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This trial targets 94 participants in total. It began in 2025-08-07 with a primary completion date of 2035-07-07.

Brief 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 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

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