Phase 3 Study of Three Cycles of Chemotherapy After Eye Removal in Patients With High-risk Stage I Retinoblastoma

What this Trial Is About

Researchers are evaluating the effect of three cycles of chemotherapy vincristine, carboplatin, and etoposide in patients with Stage I retinoblastoma who have had an eye removed enucleation. This phase 3 open-label study focuses on high-risk postenucleation retinoblastoma and aims to determine disease-free survival over five years. Participants will receive three cycles of chemotherapy once a month for three months. The chemotherapy doses are vincristine 1.5 mgm2, carboplatin 560 mgm2, and etoposide 150 mgm2. After completing treatment, patients will be followed for 60 months to monitor their health and response to the therapy. During the study, participants will be assessed regularly to track disease status and treatment effects. The main outcome measured is disease-free survival at five years. Participants will be monitored throughout the study period to evaluate the long-term effects of the chemotherapy treatment and overall health status.

Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma