Clinical Trial: Carboplatin Periocular Injection for Retinoblastoma

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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 .
Sponsor: Sun Yat-sen University

Current Primary Outcome: all cause mortality [ Time Frame: two years ]

measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years


Original Primary Outcome: Same as current

Current Secondary Outcome: side effects of carboplatin periocular injection in the Treatment of Retinoblastoma [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 10, 2014
Date Started: January 2006
Date Completion: December 2015
Last Updated: December 18, 2014
Last Verified: August 2014