CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

March 11, 2015 updated by: Huasheng Yang, Sun Yat-sen University

CEV With/Without Periocular Carboplatin Chemotherapy for Nonmetastatic Extraocular Retinoblastoma Carboplatin--A Single Center, Retrospective Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma

This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

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:

  • IRSS stage II or stage IIIa RB patients.
  • for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.
  • no tumor-related treatment was given prior to this chemotherapy regimen.

Exclusion Criteria:

  • metastasis, including lymph node metastasis.
  • the diagnosis of IRSS stage I or above in the non-target 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: CEV with/without carboplatin
CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
Drug: carboplatin periocular injection
chemotherapy together with/without 20mg/2ml carboplatin periocular injection
Other Names:
  • carboplatin
Drug: CEV chemotherapy
vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
Other Names:
  • carboplatin,vincristine, etoposide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival Rate
Time Frame: 18 months
measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
18 months

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

January 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yanghs04

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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