Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey

May 2, 2019 updated by: Bilge Batu Oto, Istanbul University - Cerrahpasa (IUC)

Retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute.

The treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa School of Medicine Ophthalmology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with retinoblastoma and who received superselective intra-arterial chemotherapy as a first line treatment or as a salvage treatment after systemic chemotherapy

Description

Inclusion Criteria:

  • patients diagnosed with unilateral/bilateral retinoblastoma

Exclusion Criteria:

  • patients with trilateral retinoblastoma
  • extraoculer involvement
  • patients with blood dyscrasias, bleeding and clotting disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Patients who received intra-arterial chemotherapy as a first line treatment
Drug: intra-arterial administration of melphalan
group 2
Patients who received intra-arterial chemotherapy as a salvage treatment after systemic chemotherapy
Drug: intra-arterial administration of melphalan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
globe salvage
Time Frame: 2-5 years
globe salvage rate after superselective intra-arterial chemotherapy treatment for retinoblastoma
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10136532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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