Trial Outcomes & Findings for CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma (NCT NCT02319486)
NCT ID: NCT02319486
Last Updated: 2015-03-30
Results Overview
measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
18 months
Results posted on
2015-03-30
Participant Flow
Object: Stage II or IIIa base on International Retinoblastoma Staging System dates: January 2009- February 2014 location: Zhongshan Ophthalmic Center
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma
Baseline characteristics by cohort
| Measure |
CEV With/Without Carboplatin
n=26 Participants
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
|
|---|---|
|
Age, Continuous
|
2.5 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
26 participants
n=5 Participants
|
|
Number of Participants
stage II
|
9 participants
n=5 Participants
|
|
Number of Participants
stage IIIa
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsmeasure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis
Outcome measures
| Measure |
CEV With/Without Carboplatin- Stage 2
n=9 Participants
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
|
CEV With/Without Carboplatin - Stage 3
n=17 Participants
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
|
|---|---|---|
|
Event Free Survival Rate
|
7 participants
|
4 participants
|
Adverse Events
CEV With/Without Carboplatin-Stage 2
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
CEV With/Without Carboplatin-Stage 3
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CEV With/Without Carboplatin-Stage 2
n=9 participants at risk
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
|
CEV With/Without Carboplatin-Stage 3
n=17 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
central nervous system metastasis
|
22.2%
2/9 • up to 2 years
|
58.8%
10/17 • up to 2 years
|
|
Eye disorders
Orbit Relapse
|
0.00%
0/9 • up to 2 years
|
5.9%
1/17 • up to 2 years
|
|
Nervous system disorders
central nervous system metastasis and orbit relapse
|
0.00%
0/9 • up to 2 years
|
11.8%
2/17 • up to 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Huasheng Yang
Zhongshan Ophthalmic Center, Sun Yat-sen University
Phone: +862087331539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place