Back to resultsTopotecan and Melphalan for Retinoblastoma
Primary Purpose
Retinoblastoma, Chemotherapy Effect
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Topotecan
Melphalan
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring Retinoblastoma, topotecan, Melphalan
Eligibility Criteria
Inclusion Criteria:
- diagnosed as retinoblastoma
- receiving eyeball-sparing treatment
Exclusion Criteria:
- disease progression during follow-up
Sites / Locations
- Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Topotecan
Melphalan
Arm Description
Topotecan intraocular injection during chemotherapy
Melphalan intraocular injection during chemotherapy
Outcomes
Primary Outcome Measures
Eyeball-sparing rate
Eyeball-sparing rate during chemotherapy in retinoblastoma patients
Secondary Outcome Measures
Side effects
Side effects during and after chemotherapy in retinoblastoma patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04799002
Brief Title
Topotecan and Melphalan for Retinoblastoma
Official Title
Choice of Topotecan or Melphalan in Retinoblastoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.
Detailed Description
To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma, Chemotherapy Effect
Keywords
Retinoblastoma, topotecan, Melphalan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topotecan
Arm Type
Active Comparator
Arm Description
Topotecan intraocular injection during chemotherapy
Arm Title
Melphalan
Arm Type
Experimental
Arm Description
Melphalan intraocular injection during chemotherapy
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Topotecan intraocular injection
Intervention Description
Topotecan intraocular injection for chemotherapy in retinoblastoma
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Melphalan intraocular injection
Intervention Description
Melphalan intraocular injection for chemotherapy in retinoblastoma
Primary Outcome Measure Information:
Title
Eyeball-sparing rate
Description
Eyeball-sparing rate during chemotherapy in retinoblastoma patients
Time Frame
5 years after chemotherapy
Secondary Outcome Measure Information:
Title
Side effects
Description
Side effects during and after chemotherapy in retinoblastoma patients
Time Frame
5 years after chemotherapy
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as retinoblastoma
receiving eyeball-sparing treatment
Exclusion Criteria:
disease progression during follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huasheng Yang
Phone
+00862087331539
Email
yanghs64@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huijing Ye
Phone
+00862087331539
Email
yehuijing@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huashen Yang
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
Huijing Ye, Doctor
Phone
00862087331539
Email
yehuijing@qq.com
First Name & Middle Initial & Last Name & Degree
Huasheng Yang, Doctor
Phone
00862087331539
Email
yanghs64@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topotecan and Melphalan for Retinoblastoma
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