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Clinical Trial NCT05080010 for Retinoblastoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma Phase 3 500

Recruiting
Clinical Trial NCT05080010 is designed to study Treatment for Retinoblastoma. It is a Phase 3 interventional study that is recruiting, having started on November 1, 2020, with plans to enroll 500 participants. Led by Sun Yat-sen University, it is expected to complete by December 31, 2030. The latest data from ClinicalTrials.gov was last updated on October 15, 2021.
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.
Detailed Description
This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.
Official Title

Three Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Study

Conditions
Retinoblastoma
Other Study IDs
  • yanghs2020
NCT ID Number
NCT05080010
Start Date (Actual)
2020-11-01
Last Update Posted
2021-10-15
Completion Date (Estimated)
2030-12-31
Enrollment (Estimated)
500
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental3 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
3 cycles chemotherapy
Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
disease-free survival
measure the disease-free survival rate at five years
five years
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • 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.

  • 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.
Sun Yat-sen University logoSun Yat-sen University1239 active studies to explore
Study Responsible Party
Huasheng Yang, Principal Investigator, Sun Yat-sen University
Study Central Contact
Contact: Huasheng Yang, M.D, PHD, +8620-87331539, [email protected]
1 Study Locations in 1 Countries

Guangdong

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, 510000, China
Huasheng Yang, M.D, PHD, Contact, +8620-87331539, [email protected]
Recruiting