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NCT04724590: ORONIN
OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA
NA trial testing IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY ) in The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients in 15 participants. Status unknown.
3 April 2021
Quick facts
| Lead sponsor | Istanbul University - Cerrahpasa |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 3 December 2020 |
| Primary completion | 3 April 2021 |
| Estimated completion | 3 May 2021 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )
Conditions studied
- The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients — all drugs for The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients →
Sponsor
Istanbul University - Cerrahpasa
Who can join
18 and older, any sex, with The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04724590
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04724590 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul University - Cerrahpasa
- Last refreshed: 26 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04724590.
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