Carboplatin Periocular Injection for Retinoblastoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma

Conditions
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Retinoblastoma

Intervention / Treatment
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* Drug: carboplatin periocular injection
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study. linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carboplatin periocular injection<br>20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) | Drug: carboplatin periocular injection<br>* 20mg/2ml carboplatin periocular injection together with chemotherapy<br>* Other names: vincristine, carboplatin, etoposide;|
| Active Comparator: chemotherapy<br>Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months | Drug: chemotherapy<br>* Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.<br>* Other names: vincristine, carboplatin, etoposide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality | measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinoblastoma, carboplatin