Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

October 2, 2021 updated by: Huasheng Yang, Sun Yat-sen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huasheng Yang, M.D, PHD
  • Phone Number: +8620-87331539
  • Email: yanghs64@126.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: five years
measure the disease-free survival rate at five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

October 2, 2021

First Submitted That Met QC Criteria

October 2, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yanghs2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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