CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Phase 4CompletedNCT02319486

Sun Yat-sen University26 enrolled

Overview

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

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 .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinoblastoma

Interventions

carboplatin periocular injectionDRUG

chemotherapy together with/without 20mg/2ml carboplatin periocular injection

CEV chemotherapyDRUG

vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Event Free Survival Rate

measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis

Time frame: 18 months

Data from ClinicalTrials.gov

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