Protons Versus Photons In Craniospinal Axis Irradiation (Picasso): A Phase 3 Randomized Controlled Trial

Children and young adults with certain brain tumors often require a type of radiotherapy called craniospinal irradiation (CSI), which treats the entire brain and spine. While this treatment can help cure the disease, it often causes serious long-term side effects such as learning difficulties, hormonal problems, hearing loss, and stroke. These side effects are particularly concerning in younger patients, as they can affect their growth, schooling, and overall quality of life. This study aims to compare two types of radiation: traditional photon-based radiotherapy and a newer technique called proton beam therapy. Proton therapy can target tumors more precisely and reduce radiation to healthy tissues, which may help lower side effects. Although earlier studies suggest that proton therapy may improve outcomes like memory, learning ability, and hormone balance, no large, high-quality trials have confirmed these benefits. In this randomized controlled trial, children and young adults aged 5 to 39 years with specific types of brain tumors will be assigned to receive either proton or photon CSI. The main goal is to assess whether proton therapy results in better functional outcomes, such as cognitive ability, hormone function, and hearing, without reducing survival. Patients will undergo regular checkups, imaging, and tests over a 2-year follow-up period. This study is being conducted at Tata Memorial Centre and will enroll participants over 5 years, with a total study duration of 7 years. The findings may help improve treatment strategies and long-term outcomes for young patients with brain tumors.