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

NCT ID: NCT04724590

Last Updated: 2021-01-26

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

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2021-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Prospective study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )

Evaluation the optic neuropathy in nasopharynx cancer patients treated in our clinic.

Intervention Type RADIATION

Other Intervention Names

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OCT(Optical Coherence Tomography), OCT-A(Optical Coherence Tomography Angiography)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Meltem Dağdelen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meltem Dağdelen

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Meltem Dağdelen, MD

Role: CONTACT

+905426603810

Ceren Barlas, MD

Role: CONTACT

+905052757730

Facility Contacts

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Meltem Dağdelen, MD

Role: primary

+905426603810

Other Identifiers

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159075

Identifier Type: OTHER

Identifier Source: secondary_id

83045809-604.01.02

Identifier Type: -

Identifier Source: org_study_id

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