Topotecan and Melphalan for Retinoblastoma

March 12, 2021 updated by: Huasheng Yang, Sun Yat-sen University

Choice of Topotecan or Melphalan in Retinoblastoma Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed as retinoblastoma
  • receiving eyeball-sparing treatment

Exclusion Criteria:

  • disease progression during follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eyeball-sparing rate
Time Frame: 5 years after chemotherapy
Eyeball-sparing rate during chemotherapy in retinoblastoma patients
5 years after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 5 years after chemotherapy
Side effects during and after chemotherapy in retinoblastoma patients
5 years after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 11, 2021

Primary Completion (ANTICIPATED)

December 30, 2024

Study Completion (ANTICIPATED)

December 30, 2027

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (ACTUAL)

March 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy Effect

Clinical Trials on Topotecan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe