Carboplatin Periocular Injection for Retinoblastoma

Overview

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.

Full Title of Study: “Carboplatin Periocular Injection in the Treatment for Retinoblastoma–A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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 .

Interventions

  • Drug: carboplatin periocular injection
    • 20mg/2ml carboplatin periocular injection together with chemotherapy
  • Drug: chemotherapy
    • Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.

Arms, Groups and Cohorts

  • Experimental: 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)
  • Active Comparator: chemotherapy
    • Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Huasheng Yang, professor – Sun Yat-sen University
  • Overall Official(s)
    • Huasheng Yang, Doctor, Study Chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Overall Contact(s)
    • Huasheng Yang, M.D, PHD, +8620-87331539, yanghs64@126.com

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