Topotecan and Melphalan for Retinoblastoma

Phase 3

Recruiting

• Conditions: Retinoblastoma; Chemotherapy Effect
• Interventions: Drug: Topotecan; Drug: Melphalan

• Registration Number: NCT04799002
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-11
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Primary Completion: 2024-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosed as retinoblastoma
• receiving eyeball-sparing treatment

Exclusion Criteria

• disease progression during follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topotecan	Topotecan	Topotecan intraocular injection during chemotherapy
Melphalan	Melphalan	Melphalan intraocular injection during chemotherapy

Primary Outcome Measures

Name	Time	Method
Eyeball-sparing rate	5 years after chemotherapy	Eyeball-sparing rate during chemotherapy in retinoblastoma patients

Secondary Outcome Measures

Name	Time	Method
Side effects	5 years after chemotherapy	Side effects during and after chemotherapy in retinoblastoma patients

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China