CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

NCT ID: NCT02319486

Last Updated: 2015-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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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 .

Conditions

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Retinoblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CEV with/without carboplatin

CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection

Group Type EXPERIMENTAL

carboplatin periocular injection

Intervention Type DRUG

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

CEV chemotherapy

Intervention Type DRUG

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

Interventions

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carboplatin periocular injection

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

Intervention Type DRUG

CEV chemotherapy

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

Intervention Type DRUG

Other Intervention Names

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carboplatin carboplatin,vincristine, etoposide

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huasheng Yang

Huasheng Yang

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huasheng Yang, M.D, PHD

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other Identifiers

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yanghs04

Identifier Type: -

Identifier Source: org_study_id

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