Carboplatin Periocular Injection for Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137928
• Other study ID #: yanghs2014
• Status: Recruiting
• Phase: Phase 3
• First received: May 10, 2014
• Last updated: December 18, 2014
• Start date: January 2006
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Sun Yat-sen University
• Contact: Huasheng Yang, M.D, PHD
• Phone: +8620-87331539
• Email: yanghs64[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 ? 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality	measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years	two years	No
Secondary	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	No