NCT05080010 Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
| NCT ID | NCT05080010 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Retinoblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 500 participants in total. It began in 2020-11-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.
Eligibility 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.
Contact & Investigator
Huasheng Yang, M.D, PHD
STUDY CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT05080010 clinical trial?
This trial is open to participants of all sexes, studying Retinoblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05080010 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 500 participants.
Is NCT05080010 currently recruiting?
Yes, NCT05080010 is actively recruiting participants. Contact the research team at yanghs64@126.com for enrollment information.
Where is the NCT05080010 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05080010 clinical trial?
NCT05080010 is sponsored by Sun Yat-sen University. The principal investigator is Huasheng Yang, M.D, PHD at Zhongshan Ophthalmic Center, Sun Yat-sen University. The trial plans to enroll 500 participants.