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CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinoblastoma

Intervention: carboplatin periocular injection (Drug); CEV chemotherapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Huasheng Yang, M.D, PHD, Study Chair, Affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University

Summary

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

Clinical Details

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

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

Primary outcome: Event Free Survival Rate

Detailed 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 .

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: January 2009
Last updated: March 11, 2015

Page last updated: August 20, 2015

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