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CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319486
Recruitment Status : Completed
First Posted : December 18, 2014
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Huasheng Yang, Sun Yat-sen University

Study Description
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Brief Summary:
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Condition or disease Intervention/treatment Phase
Retinoblastoma Drug: carboplatin periocular injection Drug: CEV chemotherapy Phase 4

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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: carboplatin periocular injection
chemotherapy together with/without 20mg/2ml carboplatin periocular injection
Other Name: carboplatin

Drug: CEV chemotherapy
vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
Other Name: carboplatin,vincristine, etoposide


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319486


Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Huasheng Yang, M.D, PHD Zhongshan Ophthalmic Center, Sun Yat-sen University
More Information
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Responsible Party: Huasheng Yang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02319486    
Other Study ID Numbers: yanghs04
First Posted: December 18, 2014    Key Record Dates
Results First Posted: March 30, 2015
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Huasheng Yang, Sun Yat-sen University:
Retinoblastoma
carboplatin
Additional relevant MeSH terms:
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Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases, Hereditary
Eye Diseases
 Retinal Diseases
Carboplatin
Etoposide
Vincristine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators