Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
Phase 3
Recruiting
- Conditions
- Retinoblastoma
- Interventions
- Drug: 3 cycles chemotherapy
- Registration Number
- NCT05080010
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3 cycles chemotherapy 3 cycles chemotherapy Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
- Primary Outcome Measures
Name Time Method disease-free survival five years measure the disease-free survival rate at five years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China