Intensity Modulated Proton therapy in pediatric brain Tumors: A Phase 3 Randomized Controlled Trial

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.

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

• The study will last 10 years (5 years to enroll patients, 5 years to follow up).

Children aged 6 to 16 years diagnosed with certain types of benign or low-grade tumours (e.g., circumscribed gliomas, low grade gliomas, low-grade glial/ glioneuronal tumors, meningioma, pituitary tumors, schwannoma, craniopharyngioma, ependymoma) will be enrolled in the study.

Patients will be randomly assigned to either IMRT or IMPT. Doctors will track survival, tumor control, cognitive function, endocrine health, and quality of life over time.