Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Retinoblastoma

Treatments: Drug: 3 cycles chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05080010

yanghs2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

3 cycles chemotherapy

Experimental group

Description:

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

Treatment:

Drug: 3 cycles chemotherapy