Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)

NCT06392906 | Recruiting Phase 3

• 1 other identifier: SI208/2024
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Associated Ophthalmopathy

Keywords

radiation therapy

Outcome Measures

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.

  6 months after initiation of IVMP

Secondary Outcomes (6)

• muscle and retrobulbar fat volume change

  6 months after initiation of IVMP

• change in diplopia

  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

Study Arms (2)

1 week external beam radiation therapy

EXPERIMENTAL

10 Gy in 5 fractions of external beam radiation therapy

Radiation: Short course radiation therapy

2 week external beam radiation therapy

ACTIVE COMPARATOR

20 Gy in 10 fractions of standard fraction external beam radiation therapy

Radiation: Standard course radiation therapy

Interventions

Short course radiation therapy RADIATION

5 daily radiation treatments

Also known as: 10 Gy in 5 fractions of radiation therapy

1 week external beam radiation therapy

Standard course radiation therapy RADIATION

10 daily radiation treatments

Also known as: 20 Gy in 10 fractions of radiation therapy

2 week external beam radiation therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Individuals with severe hypertension or diabetic retinopathy

Sponsors & Collaborators

• Janjira Petsuksiri: lead
• Mahidol University: collaborator

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok Noi, 10700, Thailand

RECRUITING

Related Publications (11)

• 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.

  PMID: 35662442 RESULT

• 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.

  PMID: 29942184 RESULT

• 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.

  PMID: 34297684 RESULT

• 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.

  PMID: 1802923 RESULT

• 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.

  PMID: 32140081 RESULT

• 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.

  PMID: 33012142 RESULT

• 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.

  PMID: 33860819 RESULT

• 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.

  PMID: 19865824 RESULT

• 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.

  PMID: 10634372 RESULT

• 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.

  PMID: 31496266 RESULT

• 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.

  PMID: 31893319 RESULT

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janjira Petsuksiri, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janjira Petsuksiri, M.D.

CONTACT

66919966662; janjira.pet@mahidol.ac.th

Wajana Thaweerat, M.D.

CONTACT

66941499212; wajana.thaweerat@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Doctor

Model Details: 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)

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: May 1, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: April 15 2024- April 15 2028
• Access Criteria: * Require researchers to demonstrate that their request for access to IPD has received ethical approval from Siriraj institution's Institutional Review Board (IRB). * Require researchers to provide a clear and specific purpose for requesting access to IPD, such as conducting further analysis, validation studies, or meta-analyses related to the research findings. * Require researchers to sign a data use agreement outlining the terms and conditions for accessing and using the IPD, including confidentiality, data security, and compliance with relevant regulations. * Request information about the researchers' plans for disseminating the findings obtained from the IPD, including intentions to publish or present the results in scientific journals, conferences, or other venues. * Consider requests from researchers interested in collaborating on future research projects or initiatives related to the research topic or dataset.

Locations

TH (1)