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NCT05080010 Clinical Trial

Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Retinoblastoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05080010
Other study ID # yanghs2020
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2020
Est. completion date December 31, 2030

Study information
Verified date October 2021
Source Sun Yat-sen University
Contact Huasheng Yang, M.D, PHD
Phone +8620-87331539
Email yanghs64@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary disease-free survival measure the disease-free survival rate at five years five years
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