Comparing short and standard radiation therapy for thyroid eye disease
Official title: Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
Run by Mahidol University · NCT06392906 · Data updated 2026-11-12
This study is testing if fewer sessions of radiation therapy can help people with moderate to severe thyroid eye disease just as well as the standard number of sessions, while also making their experience better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bangkok Noi) |
| Status | Recruiting |
| Started | July 11, 2024 |
| Main results expected | April 30, 2028 |
| Study ends | October 31, 2028 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT06392906 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 35 and older with active moderate to severe thyroid eye disease who have not responded adequately to steroid therapy.
✕Probably not a fit
Patients with severe hypertension or diabetic retinopathy may not benefit from this study due to exclusion criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of a shortened regimen of external beam radiation therapy (ERT) for patients with moderate to severe thyroid eye disease, comparing it to the standard treatment protocol. Participants will be randomized into two groups: one receiving 10 sessions of ERT and the other receiving 5 sessions. The study aims to determine if the reduced treatment schedule can maintain efficacy while improving patient quality of life. Comprehensive assessments will be conducted to monitor symptoms, vision, and overall treatment response throughout the trial.
Why it matters
Potential benefit: If successful, this study could provide a more efficient treatment option for patients with thyroid eye disease, potentially reducing treatment time and improving quality of life.
How similar studies have gone: Other studies have shown promise in using radiation therapy for thyroid eye disease, but this specific approach of reducing treatment sessions is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with active moderate to severe thyroid eye disease with a CAS \> 4 with/ without diplopia before starting IVMP * Patient with poor response to 3 doses of IVMP (CAS drop \< 1) หรือ CAS score \> 3 after 3 doses of IVMP * Patients with diplopia after 3 doses of IVMP * Patients with Graves' Ophthalmopathy who have maintained euthyroidism * Non-pregnant adults (aged 35 years or older) Exclusion Criteria: * Individuals with severe hypertension or diabetic retinopathy
Where it's running
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Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok Noi, Thailand Recruiting
Study contacts
- Principal investigator: Janjira Petsuksiri, M.D. — Mahidol University
- Study coordinator: Janjira Petsuksiri, M.D.
- Email: janjira.pet@mahidol.ac.th
- Phone: 66919966662
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.