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Topotecan and Melphalan for Retinoblastoma

Primary Purpose

Retinoblastoma, Chemotherapy Effect

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Topotecan
Melphalan
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, topotecan, Melphalan

Eligibility Criteria

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

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

First Posted
March 12, 2021
Last Updated
March 12, 2021
Sponsor
Sun Yat-sen University
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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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