Retinoblastoma
Conditions
Keywords
Retinoblastoma, carboplatin
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 .
Interventions
chemotherapy together with/without 20mg/2ml carboplatin periocular injection
DRUGCEV chemotherapy
vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival Rate | 18 months | measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis |
Participant flow
Recruitment details
Object: Stage II or IIIa base on International Retinoblastoma Staging System dates: January 2009- February 2014 location: Zhongshan Ophthalmic Center
Pre-assignment details
Exclusion Criteria: * 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. * Over Stage I base on International Retinoblastoma Staging System for the other eye.
Participants by arm
| Arm | Count |
|---|---|
| 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
carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection
CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2 | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | CEV With/Without Carboplatin |
|---|---|
| Age, Continuous | 2.5 months |
| Number of Participants stage II | 9 participants |
| Number of Participants stage IIIa | 17 participants |
| Region of Enrollment China | 26 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 17 |
| serious Total, serious adverse events | 2 / 9 | 13 / 17 |
Outcome results
Primary
Event Free Survival Rate
measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CEV With/Without Carboplatin- Stage 2 | Event Free Survival Rate | 7 participants |
| CEV With/Without Carboplatin - Stage 3 | Event Free Survival Rate | 4 participants |
p-value: 0.034pEFS