OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)
Primary Purpose
The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )
Sponsored by
About this trial
This is an interventional other trial for The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients focused on measuring RADIATION-RELATED OPTIC NEUROPATHY,NASOPHARYNGEAL CARCİNOMA, RADIOTHERAPY
Eligibility Criteria
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
Sites / Locations
- Meltem DağdelenRecruiting
Outcomes
Primary Outcome Measures
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN) RADIATION-RELATED OPTIC NEUROPATHY
RADIATION-RELATED OPTIC NEUROPATHY
Secondary Outcome Measures
Full Information
NCT ID
NCT04724590
First Posted
January 21, 2021
Last Updated
January 21, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04724590
Brief Title
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA
Acronym
ORONIN
Official Title
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
April 3, 2021 (Anticipated)
Study Completion Date
May 3, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients
Keywords
RADIATION-RELATED OPTIC NEUROPATHY,NASOPHARYNGEAL CARCİNOMA, RADIOTHERAPY
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )
Other Intervention Name(s)
OCT(Optical Coherence Tomography), OCT-A(Optical Coherence Tomography Angiography)
Intervention Description
Evaluation the optic neuropathy in nasopharynx cancer patients treated in our clinic.
Primary Outcome Measure Information:
Title
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN) RADIATION-RELATED OPTIC NEUROPATHY
Description
RADIATION-RELATED OPTIC NEUROPATHY
Time Frame
2-9 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meltem Dağdelen, MD
Phone
+905426603810
Email
meltemdagdelen@windowslive.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ceren Barlas, MD
Phone
+905052757730
Email
dr.cicibiyik@gmail.com
Facility Information:
Facility Name
Meltem Dağdelen
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meltem Dağdelen, MD
Phone
+905426603810
Email
meltemdagdelen@windowslive.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA
We'll reach out to this number within 24 hrs