Actively Recruiting
Three Cycles of Adjuvant Chemotherapy for Patients With High-risk Retinoblastoma After Enucleation: Prospective Study
Led by Sun Yat-sen University · Updated on 2021-10-15
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of three cycles of chemotherapy (vincristine, carboplatin, and etoposide) in patients with Stage I retinoblastoma who have had an eye removed (enucleation). This phase 3 open-label study focuses on high-risk postenucleation retinoblastoma and aims to determine disease-free survival over five years. Participants will receive three cycles of chemotherapy once a month for three months. The chemotherapy doses are vincristine 1.5 mg/m2, carboplatin 560 mg/m2, and etoposide 150 mg/m2. After completing treatment, patients will be followed for 60 months to monitor their health and response to the therapy. During the study, participants will be assessed regularly to track disease status and treatment effects. The main outcome measured is disease-free survival at five years. Participants will be monitored throughout the study period to evaluate the long-term effects of the chemotherapy treatment and overall health status.
CONDITIONS
Brief Title
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 based on International Retinoblastoma Staging System.
- Received enucleation in the study eye.
- Monocular retinoblastoma.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive three cycles of chemotherapy consisting of vincristine, carboplatin, and etoposide administered monthly.
3 monthly visits (in-person)
Duration - Up to 60 months
Participants are followed to monitor disease-free survival and overall health after completing chemotherapy.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Huasheng Yang, M.D, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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