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Topotecan and Melphalan for Retinoblastoma

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04799002
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
81.6
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Choice of Topotecan or Melphalan in Retinoblastoma Patients
Actual Study Start Date :
Mar 11, 2021
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Topotecan

Topotecan intraocular injection during chemotherapy

Drug: Topotecan
Topotecan intraocular injection for chemotherapy in retinoblastoma
Other Names:
  • Topotecan intraocular injection

    		•
    Experimental: Melphalan

    Melphalan intraocular injection during chemotherapy

    Drug: Melphalan
    Melphalan intraocular injection for chemotherapy in retinoblastoma
    Other Names:
  • Melphalan intraocular injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Eyeball-sparing rate [5 years after chemotherapy]

      Eyeball-sparing rate during chemotherapy in retinoblastoma patients

    Secondary Outcome Measures

    1. Side effects [5 years after chemotherapy]

      Side effects during and after chemotherapy in retinoblastoma patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • diagnosed as retinoblastoma

    • receiving eyeball-sparing treatment

    Exclusion Criteria:
    • disease progression during follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Huashen Yang, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huasheng Yang, Principal Investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04799002
    Other Study ID Numbers:
    • 202103
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Huasheng Yang, Principal Investigator, Sun Yat-sen University
    Retinoblastoma
    topotecan
    Melphalan
    Additional relevant MeSH terms:
    Retinoblastoma
    Melphalan
    Topotecan

    Study Results

    No Results Posted as of Mar 16, 2021