Carboplatin Periocular Injection for Retinoblastoma

NCT ID: NCT02137928

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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 .

Conditions

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Retinoblastoma

Keywords

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Retinoblastoma carboplatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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carboplatin periocular injection

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)

Group Type EXPERIMENTAL

carboplatin periocular injection

Intervention Type DRUG

20mg/2ml carboplatin periocular injection together with chemotherapy

chemotherapy

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

Group Type ACTIVE_COMPARATOR

chemotherapy

Intervention Type DRUG

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

Interventions

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carboplatin periocular injection

20mg/2ml carboplatin periocular injection together with chemotherapy

Intervention Type DRUG

chemotherapy

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

Intervention Type DRUG

Other Intervention Names

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carboplatin vincristine, carboplatin, etoposide vincristine, carboplatin, etoposide

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huasheng Yang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huasheng Yang, Doctor

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huasheng Yang, M.D, PHD

Role: CONTACT

Phone: +8620-87331539

Email: [email protected]

Facility Contacts

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Huasheng Yang, M.D, PHD

Role: primary

Other Identifiers

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yanghs2014

Identifier Type: -

Identifier Source: org_study_id