CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

CEV With/Without Periocular Carboplatin Chemotherapy for Nonmetastatic Extraocular Retinoblastoma Carboplatin--A Single Center, Retrospective Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319486
• Other study ID #: yanghs04
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2014
• Last updated: March 11, 2015
• Start date: January 2009
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Description:

This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• IRSS stage II or stage IIIa RB patients.

• for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.

• no tumor-related treatment was given prior to this chemotherapy regimen.

Exclusion Criteria:

• metastasis, including lymph node metastasis.

• the diagnosis of IRSS stage I or above in the non-target eye.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• carboplatin periocular injection
chemotherapy together with/without 20mg/2ml carboplatin periocular injection
• CEV chemotherapy
vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival Rate	measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis	18 months	Yes