Retinoblastoma
Conditions
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.
Interventions
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | five years | measure the disease-free survival rate at five years |
Countries
China
Contacts
Primary ContactHuasheng Yang, M.D, PHD
Outcome results
None listed