Carboplatin Periocular Injection for Retinoblastoma

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Brief Title

Carboplatin Periocular Injection for Retinoblastoma

Official Title

Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma

Brief Summary

      This study will evaluate the clinical efficacy of periocular injections of carboplatin
      together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy
      alone.
    

Detailed Description

      This study will be a phase Ⅲ open label interventional case series. Patients with
      retinoblastoma will be randomized to receive chemotherapy with or without periocular
      injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin
      periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be
      followed for 24 months .
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

all cause mortality

Secondary Outcome

 side effects of carboplatin periocular injection in the Treatment of Retinoblastoma

Condition

Retinoblastoma

Intervention

carboplatin periocular injection

Study Arms / Comparison Groups

 carboplatin periocular injection
Description:  20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

January 2006

Completion Date

December 2015

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study.

          -  linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma
             Staging System.

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Huasheng Yang, Doctor, +8620-87331539, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02137928

Organization ID

yanghs2014


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Huasheng Yang, Doctor, Study Chair, Zhongshan Ophthalmic Center, Sun Yat-sen University


Verification Date

August 2014