Topotecan and Melphalan for Retinoblastoma
Choice of Topotecan or Melphalan in Retinoblastoma Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2021
CompletedFirst Submitted
Initial submission to the registry
March 12, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
ExpectedMarch 16, 2021
March 1, 2021
3.8 years
March 12, 2021
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eyeball-sparing rate
Eyeball-sparing rate during chemotherapy in retinoblastoma patients
5 years after chemotherapy
Secondary Outcomes (1)
Side effects
5 years after chemotherapy
Study Arms (2)
Topotecan
ACTIVE COMPARATORTopotecan intraocular injection during chemotherapy
Melphalan
EXPERIMENTALMelphalan intraocular injection during chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed as retinoblastoma
- receiving eyeball-sparing treatment
You may not qualify if:
- disease progression during follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huashen Yang
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2021
First Posted
March 16, 2021
Study Start
March 11, 2021
Primary Completion
December 30, 2024
Study Completion (Estimated)
December 30, 2027
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share