Carboplatin Periocular Injection for Retinoblastoma

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Retinoblastoma

Treatments: Drug: chemotherapy; Drug: carboplatin periocular injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02137928

yanghs2014

Details and patient eligibility

About

This study will evaluate the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

Full description

This study will be a phase Ⅲ open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

carboplatin periocular injection

Experimental group

Description:

20mg/2ml carboplatin periocular injection together with CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months)

Treatment:

Drug: carboplatin periocular injection

chemotherapy

Active Comparator group

Description:

Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months

Treatment:

Drug: chemotherapy