This study will evaluate the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.
This study will be a phase Ⅲ open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
20mg/2ml carboplatin periocular injection together with chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGall cause mortality
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Time frame: two years
side effects of carboplatin periocular injection in the Treatment of Retinoblastoma
Measure the side effects(systemic check-up, local side effects) before each treatment, and 1,3,6,9,12,18,24 months after the treatment.
Time frame: two years
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