Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392906
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-03-30
Brief Title:
Orbital Radiotherapy in Graves Ophthalmopathy 1 Week vs 2 Weeks OraGO-1 Trial
Sponsor:
Janjira Petsuksiri
Organization:
Mahidol University
Study Overview
Official Title:
Orbital Radiotherapy in Graves Ophthalmopathy 1 Week vs 2 Weeks A Phase II Randomized Controlled Trial OraGO-1 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None