Carboplatin Periocular Injection for Retinoblastoma

Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137928

Enrollment

Registered

2014-05-14

Start date

2006-01-31

Completion date

2015-12-31

Last updated

2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinoblastoma

Keywords

Retinoblastoma, carboplatin

Brief summary

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.

Detailed 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 .

Interventions

DRUGcarboplatin periocular injection

20mg/2ml carboplatin periocular injection together with chemotherapy

DRUGchemotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
all cause mortality	two years	measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at two years

Secondary

Measure	Time frame	Description
side effects of carboplatin periocular injection in the Treatment of Retinoblastoma	two years	Measure the side effects(systemic check-up, local side effects) before each treatment, and 1,3,6,9,12,18,24 months after the treatment.

Countries

China

Contacts

Primary ContactHuasheng Yang, M.D, PHD

yanghs64@126.com+8620-87331539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026