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Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

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Phase 3

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Overview

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

Description

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.

Eligibility

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.

Study details
    Retinoblastoma

NCT05080010

Sun Yat-sen University

27 January 2024

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