Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Clinical Activity Score (CAS) change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
In this study, both participants and researchers are aware of the treatment administered due to the necessity for close monitoring of treatment outcomes and side effects by radiation oncologists and ophthalmologists.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Individuals with severe hypertension or diabetic retinopathy
结局指标
主要结局
Clinical Activity Score (CAS) change
时间窗: 6 months after initiation of IVMP
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.
次要结局
- change in diplopia(6 months after initiation of IVMP)
- muscle and retrobulbar fat volume change(6 months after initiation of IVMP)
- change in quality of life(6 months after initiation of IVMP)
- Radiation toxicities(6 months after initiation of IVMP)
- Visual acuity (VA)(6 months after initiation of IVMP)
- Visual field (VF)(6 months after initiation of IVMP)
研究者
Janjira Petsuksiri
Associate Professor Doctor
Mahidol University