Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Phase 3RecruitingNCT05080010

Sun Yat-sen University500 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Retinoblastoma

Interventions

3 cycles chemotherapyDRUG

Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

disease-free survival

measure the disease-free survival rate at five years

Time frame: five years

Central Contacts

Huasheng Yang, M.D, PHD

CONTACT

+8620-87331539 yanghs64@126.com

Data from ClinicalTrials.gov

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