Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

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Brief Title

Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation

Official Title

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

Brief Summary

      The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) are as
      effective as 6 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 be randomized to receive chemotherapy(CEV) of 3 cycles or 6
      cycles on a monthly basis. Patients will be followed for 24 months.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

disease-free survival

Secondary Outcome

 side effects of chemotherapy in the Treatment of Retinoblastoma

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

181

Start Date

January 2013

Completion Date

December 2023

Primary Completion Date

December 2023

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, Doctor, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01906814

Organization ID

yanghs20130507

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Collaborators

 Fudan University

Study Sponsor

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

Verification Date

October 2020