CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

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

Completed

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Key information

Conditions

Retinoblastoma Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Retinal Diseases Retinal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carboplatin periocular injection

Drug

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

Other names: carboplatin

CEV chemotherapy

Drug

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

Other names: carboplatin,vincristine, etoposide

Primary outcomes

Event Free Survival Rate

Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Dec 18, 2014
Registry last updated: Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed