Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
ConditionThyroid Associated Ophthalmopathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJanjira Petsuksiri
About this trial
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Individuals with severe hypertension or diabetic retinopathy
Trial design
Design model
Parallel
Treatments tested in this trial
Short course radiation therapy
Radiation5 daily radiation treatments
Standard course radiation therapy
Radiation10 daily radiation treatments
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: 1 week external beam radiation therapyExperimental treatment 1 intervention
Group B: 2 week external beam radiation therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Activity Score (CAS) change
To evaluate the non-inferiority of outcomes in terms of the patient's proportion of converting from active (CAS \> 4) to inactive eye disease (CAS \<3) with CAS drop \> 2 points, following orbital radiotherapy in combination with IVMP, comparing standard and reduced-dose orbital radiotherapy CAS score range from 1-7, initially and range from 1-10 at 1-3 months follow-up period. Higher CAS scores represented worse outcomes.
Time frame
6 months after initiation of IVMPSecondary outcomes
1
muscle and retrobulbar fat volume change
To compare the change in volume of extra-ocular muscles and retro bulbar fat after orbital radiotherapy, comparing standard with reduced-dose orbital radiotherapy
Time frame
6 months after initiation of IVMP2
change in diplopia
To compare the difference in prism deviation in primary gaze after standard and reduced-dose orbital radiotherapy
Time frame
6 months after initiation of IVMP3
change in quality of life
To compare the difference in Graves' ophthalmopathy quality of life (GO-QOL) scores (Thai version) between standard and reduced-dose orbital radiotherapy. The total QOL scores range from 0 to 100 with higher scores indicating a better health status.
Time frame
6 months after initiation of IVMP4
Radiation toxicities
To compare the summation of the Radiation Therapy Oncology Group (RTOG) toxicity scores (including dry eye, eye pain, keratitis, eyelid, conjunctiva, lacrimal gland, cornea, iris and skin toxicities) after standard and reduced-dose orbital radiotherapy. The RTOG gradings range from grade 0 to grade 4 in each item. The total toxicity scores range from 0-34, with a higher score indicating more severe side effects.
Time frame
6 months after initiation of IVMPSponsors and contacts
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Source ClinicalTrials.gov