Phase 4
N=26
CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma
Retinoblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02319486 ↗Enrolled (actual)
26
Serious AEs
57.7%
Results posted
Mar 2015
Primary outcome: Primary: Event Free Survival Rate — 7; 4 participants — p=0.034
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- carboplatin periocular injection (Drug); CEV chemotherapy (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Sun Yat-sen University
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Free Survival Rate |
7; 4 | 0.034 sig |
Summary
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02319486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.