Status:
ACTIVE_NOT_RECRUITING
Adjuvant Chemotherapy for High-risk Retinoblastoma After Enucleation
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Fudan University
Conditions:
Retinoblastoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether 3 cycles of chemotherapy(CEV) is not inferior to 6 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.
Detailed Description
This study will be a phase Ⅲ open label interventional case series. Patients with unilateral Stage I enucleated retinoblastoma will be randomized to receive chemotherapy(CEV) of 3 cycles or 6 cycles e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01906814
Start Date
August 1 2013
End Date
April 1 2024
Last Update
April 9 2024
Active Locations (1)
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1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000