Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05080010

Collaborator

(none)

500

Enrollment

Location

Arm

122

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma	Drug: 3 cycles chemotherapy	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 cycles chemotherapy Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.	Drug: 3 cycles chemotherapy Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months. Other Names: vincristine, carboplatin, etoposide

Arm

Intervention/Treatment

Experimental: 3 cycles chemotherapy

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

Drug: 3 cycles chemotherapy

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

Other Names:

vincristine, carboplatin, etoposide

Outcome Measures

Primary Outcome Measures

disease-free survival [five years]
measure the disease-free survival rate at five years

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Study Chair: Huasheng Yang, M.D, PHD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huasheng Yang, Sun Yat-sen University, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT05080010

Other Study ID Numbers:

yanghs2020

First Posted:

Oct 15, 2021

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021