Study of New Eye-Saving Treatments for Retinoblastoma in Children Up to 6 Years Old Comparing Intra-Arterial Chemotherapy with Other Conservative Therapies and Their Effects on Vision

What this Trial Is About

Researchers are evaluating new conservative treatments for retinoblastoma, a type of eye cancer affecting children. This research includes two separate studies a randomized phase II trial testing the effectiveness of intra-arterial chemotherapy IAC using melphalan alone versus melphalan combined with topotecan, both alongside eye treatments and a minimally invasive study assessing visual function after intravenous chemotherapy combined with local eye treatments or local treatment alone without chemotherapy. The goal is to improve disease control and vision outcomes in young patients with retinoblastoma. In the first study, children receive 2 to 6 monthly cycles of IAC delivered by catheter directly into the ophthalmic artery under general anesthesia. The second study involves 2 to 6 cycles of intravenous chemotherapy with etoposide, carboplatin, and vincristine, combined with eye treatments like thermotherapy, cryotherapy, iodine-125 plaques, or intravitreal melphalan injections. Both studies focus on patients with specific retinoblastoma classifications and eligibility for conservative eye management. Participants will undergo follow-up for at least 24 months, including evaluations of eye preservation rates and visual function when patients reach six years old. Researchers will monitor ocular and systemic toxicity, relapse occurrences, second cancers, retinal health, and school integration. Treatment visits, ophthalmologic assessments, and safety checks are included to track progress and outcomes over time, with a total observation period extending up to 24 months after study entry.

Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome