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