Chemotherapy for high-risk retinoblastoma after eye removal
Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05080010 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with Stage I enucleated retinoblastoma who have undergone surgical removal of the affected eye.
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.
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 performed: Previous studies have shown promising results with adjuvant chemotherapy in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Huasheng Yang, M.D, PHD
- Email: yanghs64@126.com
- Phone: +8620-87331539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.