Clinical trial NCT06392906: Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
Official title: Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Associated Ophthalmopathy
Keywords: radiation therapy
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2024-05-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2 randomized control trial comparing between standard radiation therapy arm (20 Gy in 10 fractions) and experimental radiation therapy arm (10 Gy in 5 fractions)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily External Beam Radiation Therapy (ERT).

The primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy.

By comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease.

Participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ERT. Throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. These evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.

Eligibility 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

Primary outcomes:
measure: Clinical Activity Score (CAS) change
timeFrame: 6 months after initiation of IVMP
Secondary outcomes:
measure: muscle and retrobulbar fat volume change
timeFrame: 6 months after initiation of IVMP
measure: change in diplopia
timeFrame: 6 months after initiation of IVMP
measure: change in quality of life
timeFrame: 6 months after initiation of IVMP
measure: Radiation toxicities
timeFrame: 6 months after initiation of IVMP
measure: Visual acuity (VA)
timeFrame: 6 months after initiation of IVMP
measure: Visual field (VF)
timeFrame: 6 months after initiation of IVMP
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital Mahidol University
Study officials:
affiliation: Mahidol University
name: Janjira Petsuksiri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoang TD, Stocker DJ, Chou EL, Burch HB. 2022 Update on Clinical Management of Graves Disease and Thyroid Eye Disease. Endocrinol Metab Clin North Am. 2022 Jun;51(2):287-304. doi: 10.1016/j.ecl.2021.12.004. Epub 2022 May 11.
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citation: Kim M, Chang JH, Lee NK. Quantitative analysis of extraocular muscle volume and exophthalmos reduction after radiation therapy to treat Graves' ophthalmopathy: A pilot study. Eur J Ophthalmol. 2021 Mar;31(2):340-345. doi: 10.1177/1120672119873841. Epub 2019 Sep 9.
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