Carboplatin Periocular Injection for Retinoblastoma

Phase 3

• Conditions: Retinoblastoma
• Interventions: Drug: carboplatin periocular injection; Drug: chemotherapy

• Registration Number: NCT02137928
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2014-05-10
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Status Verified: 2014-08
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carboplatin periocular injection	carboplatin periocular injection	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)
chemotherapy	chemotherapy	Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months

Primary Outcome Measures

Name	Time	Method
all cause mortality	two years	measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years

Secondary Outcome Measures

Name	Time	Method
side effects of carboplatin periocular injection in the Treatment of Retinoblastoma	two years	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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China