CEV With/Without Periocular Carboplatin Chemotherapy for Nonmetastatic Extraocular Retinoblastoma Carboplatin--A Single Center, Retrospective Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Primary Endpoint
- Event Free Survival Rate
Study Overview
Brief Summary
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma
Detailed Description
This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IRSS stage II or stage IIIa RB patients.
- •for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.
- •no tumor-related treatment was given prior to this chemotherapy regimen.
Exclusion Criteria
- •metastasis, including lymph node metastasis.
- •the diagnosis of IRSS stage I or above in the non-target eye.
Arms & Interventions
CEV with/without carboplatin
CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
Intervention: CEV chemotherapy (Drug)
CEV with/without carboplatin
CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
Intervention: carboplatin periocular injection (Drug)
Outcomes
Primary Outcomes
Event Free Survival Rate
Time Frame: 18 months
measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
Secondary Outcomes
No secondary outcomes reported
Investigators
Huasheng Yang
Huasheng Yang
Sun Yat-sen University