Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study

The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
• Received enucleation in the study eye.
• Monocular retinoblastoma.

Exclusion Criteria:

• Any previous disease in the study eye.
• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
• History of chemical intervention for retinoblastoma in the study eye.