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