OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)

January 21, 2021 updated by: Meltem Dağdelen, Istanbul University - Cerrahpasa (IUC)

OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)

Primary treatment in nasopharynx cancers is radiotherapy (RT) or chemoradiotherapy (CRT) depending on the stage of the tumor. According to the guidelines, the dose of radiotherapy for primary tumors varies between 66-70 Gy. In consideration of modern radiotherapy techniques like IMRT with systemic chemotherapy for nasopharyngeal cancer, loco-regional control has been perfect. However, the rate of late complications from treatment, many of which are irreversible, is still high. Radiation-related optic neuropathy is the late complication that optic nerves might be affected during the radiotherapy due to the close location of the nasopharynx. Incidence of this is 8.7-9% in head and neck cancer and is observed between 2-9 years after RT. Painless, irreversible, and progressive vision loss usually occurs, and the pallor of optic disc margins, retinal vein dilatation, bleeding, and neovascularization are in the ophthalmic examination. The risk of optic neuropathy increases when the tumor is in close contact with optic nerves, radiation dose, concurrent chemotherapy used, history of diabetes or hypertension.

The aim of our study is to prospectively evaluate optic neuropathy in nasopharynx cancer patients treated in our clinic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient with nasopharyngeal carcinoma that histopathologically confirmed Age >18 Radiotherapy or chemoradiotherapy applied to the patient in our clinic No recurrence or metastasis during follow-up Optic evaluation Evaluation with MRI or CT during follow-up

Exclusion Criteria:

Cranial RT No histopathological verification Age< 18 There were locoregional recurrence or metastasis

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN) RADIATION-RELATED OPTIC NEUROPATHY
Time Frame: 2-9 years
RADIATION-RELATED OPTIC NEUROPATHY
2-9 years

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

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)

December 3, 2020

Primary Completion (Anticipated)

April 3, 2021

Study Completion (Anticipated)

May 3, 2021

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83045809-604.01.02
  • 159075 (Other Identifier: IstanbulUC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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