This clinical trial is focused on studying a type of eye cancer called Retinoblastoma, which primarily affects young children. The study is specifically looking at cases where the cancer is present in one eye and has been treated by removing the affected eye, a procedure known as primary enucleation. The purpose of the study is to understand how well additional treatments, known as adjuvant treatments, work in preventing the cancer from coming back. These treatments are given after the surgery to address any remaining cancer risk factors identified through examining the removed tissue.

The study involves several medications that are used as part of the adjuvant treatment. These include ONCOVIN (vincristine sulfate), THIOTEPA (found in both THIOTEPA GENOPHARM and TEPADINA), ENDOXAN (cyclophosphamide), ETOPOSIDE TEVA (etoposide), and CARBOPLATINE TEVA (carboplatin). These medications are administered through injections or infusions, which are methods of delivering the drugs directly into the bloodstream or body. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual drugs.

Participants in the study will receive these treatments and be monitored over time to see if the cancer returns and to evaluate any side effects from the treatments. The study will also look at the long-term effects of the treatments and how they impact the patients’ overall health. Additionally, researchers will study the genetic makeup of the tumors and use imaging techniques like MRI to detect any spread of the cancer beyond the eye. The study aims to provide valuable information that could improve treatment strategies for children with retinoblastoma in the future.