Clinical trial Recruiting at 1 site Phase 3 Interventional

Chemotherapy for high-risk retinoblastoma after eye removal

Official title: Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study

Run by Sun Yat-sen University · NCT05080010 · Data updated 2026-11-12

This study is testing if giving chemotherapy after removing the eye can help prevent high-risk retinoblastoma from coming back in children with Stage I disease.

Quick facts

PhasePhase 3
Study typeInterventional
SexAll
Enrollment500 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedNovember 1, 2020
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedOctober 15, 2021
Trial IDNCT05080010 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children diagnosed with Stage I enucleated retinoblastoma who have undergone surgical removal of the affected eye.

Probably not a fit

Patients with previous diseases in the study eye or those who have undergone prior treatments for retinoblastoma may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study aims to evaluate the effectiveness of three cycles of chemotherapy (CEV) in patients with Stage I enucleated retinoblastoma. Participants will receive chemotherapy on a monthly basis and will be monitored for a duration of 60 months to assess treatment outcomes. The study is designed to provide insights into the potential benefits of adjuvant chemotherapy in preventing recurrence of retinoblastoma after surgical removal of the affected eye.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence in children with high-risk retinoblastoma.

How similar studies have gone: Previous studies have shown promising results with adjuvant chemotherapy in similar patient populations, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
* Received enucleation in the study eye.
* Monocular retinoblastoma.

Exclusion Criteria:

* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* History of chemical intervention for retinoblastoma in the study eye.

Where it's running

  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.