RecruitingPhase 3NCT05080010
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study
Sponsor
Sun Yat-sen University
Enrollment
500 participants
Start Date
Nov 1, 2020
Study Type
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
DRUG3 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05080010
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