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

NCT03935074 | Completed

• 1 other identifier: 10136532
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinoblastoma

Keywords

enucleation; globe salvage; superselective intra-arterial chemotherapy

Outcome Measures

Primary Outcomes (1)

• globe salvage

  globe salvage rate after superselective intra-arterial chemotherapy treatment for retinoblastoma

  2-5 years

Study Arms (2)

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

Interventions

intra-arterial administration of melphalan DRUG

group 1; group 2

Eligibility Criteria

• Age: 5 Months - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• patients diagnosed with unilateral/bilateral retinoblastoma

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa School of Medicine Ophthalmology Department

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

• Saglam M, Sarici A, Anagnostakou V, Yildiz B, Kocer N, Islak C, Kizilkilic O. An alternative technique of the superselective catheterization of the ophthalmic artery for intra-arterial chemotherapy of the retinoblastoma: retrograde approach through the posterior communicating artery to the ophthalmic artery. Neuroradiology. 2014 Sep;56(9):751-4. doi: 10.1007/s00234-014-1388-1. Epub 2014 Jun 10.

  PMID: 24913287 BACKGROUND

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Specialist, Medical Doctor

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: August 30, 2016
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)