Retinoblastoma Clinical Trial
Official title:
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
Verified date | March 2015 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma
Status | Completed |
Enrollment | 26 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event Free Survival Rate | measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis | 18 months | Yes |
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