Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

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Brief Title

Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

Official Title

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

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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

disease-free survival


Condition

Retinoblastoma

Intervention

3 cycles chemotherapy

Study Arms / Comparison Groups

 3 cycles chemotherapy
Description:  Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three 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

500

Start Date

November 1, 2020

Completion Date

December 31, 2030

Primary Completion Date

December 31, 2030

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Huasheng Yang, M.D, PHD, +8620-87331539, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05080010

Organization ID

yanghs2020


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

October 2021