Brief Title
CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma
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
Brief Summary
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Event Free Survival Rate
Condition
Retinoblastoma
Intervention
carboplatin periocular injection
Study Arms / Comparison Groups
CEV with/without carboplatin
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
26
Start Date
January 2009
Completion Date
April 2014
Primary Completion Date
April 2014
Eligibility 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Huasheng Yang, M.D, PHD, ,
Administrative Informations
NCT ID
NCT02319486
Organization ID
yanghs04
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Huasheng Yang, M.D, PHD, Study Chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
Verification Date
March 2015