CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

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Brief Title

CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Official Title

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

Brief Summary

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

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Event Free Survival Rate

Condition

Retinoblastoma

Intervention

carboplatin periocular injection

Study Arms / Comparison Groups

 CEV with/without carboplatin
Description:  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

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

26

Start Date

January 2009

Completion Date

April 2014

Primary Completion Date

April 2014

Eligibility Criteria

        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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Huasheng Yang, M.D, PHD, ,

Administrative Informations

NCT ID

NCT02319486

Organization ID

yanghs04

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

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

Verification Date

March 2015