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CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Primary Purpose

Retinoblastoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
carboplatin periocular injection
CEV chemotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinoblastoma focused on measuring Retinoblastoma, carboplatin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CEV with/without carboplatin

    Arm 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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 15, 2014
    Last Updated
    March 11, 2015
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02319486
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinoblastoma
    Keywords
    Retinoblastoma, carboplatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CEV with/without carboplatin
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin periocular injection
    Other Intervention Name(s)
    carboplatin
    Intervention Description
    chemotherapy together with/without 20mg/2ml carboplatin periocular injection
    Intervention Type
    Drug
    Intervention Name(s)
    CEV chemotherapy
    Other Intervention Name(s)
    carboplatin,vincristine, etoposide
    Intervention Description
    vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
    Primary Outcome Measure Information:
    Title
    Event Free Survival Rate
    Description
    measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huasheng Yang, M.D, PHD
    Organizational Affiliation
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

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