Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
NCT ID: NCT06392906
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
68 participants
INTERVENTIONAL
2024-07-11
2028-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 week external beam radiation therapy
10 Gy in 5 fractions of external beam radiation therapy
Short course radiation therapy
5 daily radiation treatments
2 week external beam radiation therapy
20 Gy in 10 fractions of standard fraction external beam radiation therapy
Standard course radiation therapy
10 daily radiation treatments
Interventions
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Short course radiation therapy
5 daily radiation treatments
Standard course radiation therapy
10 daily radiation treatments
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Janjira Petsuksiri
OTHER
Responsible Party
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Janjira Petsuksiri
Associate Professor Doctor
Principal Investigators
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Janjira Petsuksiri, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok Noi, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
San Miguel I, Arenas M, Carmona R, Rutllan J, Medina-Rivero F, Lara P. Review of the treatment of Graves' ophthalmopathy: The role of the new radiation techniques. Saudi J Ophthalmol. 2018 Apr-Jun;32(2):139-145. doi: 10.1016/j.sjopt.2017.09.003. Epub 2017 Sep 21.
Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479.
Marcocci C, Bartalena L, Bogazzi F, Bruno-Bossio G, Lepri A, Pinchera A. Orbital radiotherapy combined with high dose systemic glucocorticoids for Graves' ophthalmopathy is more effective than radiotherapy alone: results of a prospective randomized study. J Endocrinol Invest. 1991 Nov;14(10):853-60. doi: 10.1007/BF03347943.
Torres Royo L, Antelo Redondo G, Arquez Pianetta M, Arenas Prat M. Low-Dose radiation therapy for benign pathologies. Rep Pract Oncol Radiother. 2020 Mar-Apr;25(2):250-254. doi: 10.1016/j.rpor.2020.02.004. Epub 2020 Feb 22.
Abdus-Salam AA, Olabumuyi AA, Jimoh MA, Folorunso SA, Orekoya AA. The role of radiation treatment in the management of inflammatory musculoskeletal conditions: a revisit. Radiat Oncol J. 2020 Sep;38(3):151-161. doi: 10.3857/roj.2020.00178. Epub 2020 Jun 18.
Weissmann T, Lettmaier S, Donaubauer AJ, Bert C, Schmidt M, Kruse F, Ott O, Hecht M, Fietkau R, Frey B, Putz F. Low- vs. high-dose radiotherapy in Graves' ophthalmopathy: a retrospective comparison of long-term results. Strahlenther Onkol. 2021 Oct;197(10):885-894. doi: 10.1007/s00066-021-01770-9. Epub 2021 Apr 16.
Johnson KT, Wittig A, Loesch C, Esser J, Sauerwein W, Eckstein AK. A retrospective study on the efficacy of total absorbed orbital doses of 12, 16 and 20 Gy combined with systemic steroid treatment in patients with Graves' orbitopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jan;248(1):103-9. doi: 10.1007/s00417-009-1214-3. Epub 2009 Oct 29.
Kahaly GJ, Rosler HP, Pitz S, Hommel G. Low- versus high-dose radiotherapy for Graves' ophthalmopathy: a randomized, single blind trial. J Clin Endocrinol Metab. 2000 Jan;85(1):102-8. doi: 10.1210/jcem.85.1.6257.
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.
Lumyongsatien M, Keeratidamkerngsakul B, Pornpanich K, Vangveeravong S, Saonanon P, Wiwatwongwana D, Mahaisavariya P, Aryasit O, Pongpirul K. Development and psychometric properties of the Thai Graves' ophthalmopathy quality of life (GO-QOL) questionnaire. J Patient Rep Outcomes. 2019 Dec 31;4(1):1. doi: 10.1186/s41687-019-0164-8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SI208/2024
Identifier Type: -
Identifier Source: org_study_id