Back to resultsCarboplatin Periocular Injection for Retinoblastoma
Primary Purpose
Retinoblastoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
carboplatin periocular injection
chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring Retinoblastoma, carboplatin
Eligibility Criteria
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System.
Exclusion Criteria:
- Any previous disease in the study eye.
- Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
- History of chemical intervention for retinoblastoma in the study eye.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
carboplatin periocular injection
chemotherapy
Arm Description
20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months)
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months
Outcomes
Primary Outcome Measures
all cause mortality
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Secondary Outcome Measures
side effects of carboplatin periocular injection in the Treatment of Retinoblastoma
Measure the side effects(systemic check-up, local side effects) before each treatment, and 1,3,6,9,12,18,24 months after the treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02137928
Brief Title
Carboplatin Periocular Injection for Retinoblastoma
Official Title
Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
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 the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.
Detailed Description
This study will be a phase Ⅲ open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
carboplatin periocular injection
Arm Type
Experimental
Arm Description
20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months)
Arm Title
chemotherapy
Arm Type
Active Comparator
Arm Description
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months
Intervention Type
Drug
Intervention Name(s)
carboplatin periocular injection
Other Intervention Name(s)
carboplatin, vincristine, carboplatin, etoposide
Intervention Description
20mg/2ml carboplatin periocular injection together with chemotherapy
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
vincristine, carboplatin, etoposide
Intervention Description
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
Primary Outcome Measure Information:
Title
all cause mortality
Description
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years
Time Frame
two years
Secondary Outcome Measure Information:
Title
side effects of carboplatin periocular injection in the Treatment of Retinoblastoma
Description
Measure the side effects(systemic check-up, local side effects) before each treatment, and 1,3,6,9,12,18,24 months after the treatment.
Time Frame
two years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to provide written informed consent and comply with study assessments for the full duration of the study.
linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System.
Exclusion Criteria:
Any previous disease in the study eye.
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
History of chemical intervention for retinoblastoma in the study eye.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, Doctor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, M.D, PHD
Phone
+8620-87331539
Email
yanghs64@126.com
12. IPD Sharing Statement
Learn more about this trial
Carboplatin Periocular Injection for Retinoblastoma
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