Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma
ConditionRetinoblastoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSun Yat-sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
3 cycles chemotherapy
DrugChemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: 3 cycles chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
disease-free survival
measure the disease-free survival rate at five years
Time frame
five yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov