Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
Key facts
- Who runs it
- Janjira Petsuksiri
- Where
- Thailand1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 68 people, planned
- Started
- 11 Jul 2024
- Expected to end
- 31 Oct 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Short course radiation therapy
- Standard course radiation therapy
- Record updated
- 4 December 2024
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- Individuals with severe hypertension or diabetic retinopathy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. This condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss.
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Primary treatment modalities are intravenous methylprednisolone (IVMP) and other medications for patients with moderate to severe and active thyroid eye disease. In addition, external beam radiation therapy (ERT) is an another treatment option in combination with IVMP.
Radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. This approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares.
This study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ERT to a standard protocol of 10 treatments. The primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.
The 2 groups in the trial
- 1 week external beam radiation therapyTreatment being tested
10 Gy in 5 fractions of external beam radiation therapy
Treatment: Short course radiation therapy
- 2 week external beam radiation therapyExisting treatment, for comparison
20 Gy in 10 fractions of standard fraction external beam radiation therapy
Treatment: Standard course radiation therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
- Fit questions
- Built from NCT06392906, who can take part
- Record updated
- 4 December 2024