CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: Retinoblastoma

Treatments: Drug: CEV chemotherapy; Drug: carboplatin periocular injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02319486

yanghs04

Details and patient eligibility

About

This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Full 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 .

Enrollment: 26 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

CEV with/without carboplatin

Experimental group

Description:

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

Treatment:

Drug: carboplatin periocular injection

Drug: CEV chemotherapy