Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT06392906
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-15', 'size': 385410, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-27T04:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-04-27', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Activity Score (CAS) change', 'timeFrame': '6 months after initiation of IVMP', 'description': "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\n\nCAS score range from 1-7, initially and range from 1-10 at 1-3 months follow-up period. Higher CAS scores represented worse outcomes."}], 'secondaryOutcomes': [{'measure': 'muscle and retrobulbar fat volume change', 'timeFrame': '6 months after initiation of IVMP', 'description': 'To compare the change in volume of extra-ocular muscles and retro bulbar fat after orbital radiotherapy, comparing standard with reduced-dose orbital radiotherapy'}, {'measure': 'change in diplopia', 'timeFrame': '6 months after initiation of IVMP', 'description': 'To compare the difference in prism deviation in primary gaze after standard and reduced-dose orbital radiotherapy'}, {'measure': 'change in quality of life', 'timeFrame': '6 months after initiation of IVMP', 'description': "To compare the difference in Graves' ophthalmopathy quality of life (GO-QOL) scores (Thai version) between standard and reduced-dose orbital radiotherapy. The total QOL scores range from 0 to 100 with higher scores indicating a better health status."}, {'measure': 'Radiation toxicities', 'timeFrame': '6 months after initiation of IVMP', 'description': 'To compare the summation of the Radiation Therapy Oncology Group (RTOG) toxicity scores (including dry eye, eye pain, keratitis, eyelid, conjunctiva, lacrimal gland, cornea, iris and skin toxicities) after standard and reduced-dose orbital radiotherapy. The RTOG gradings range from grade 0 to grade 4 in each item. The total toxicity scores range from 0-34, with a higher score indicating more severe side effects.'}, {'measure': 'Visual acuity (VA)', 'timeFrame': '6 months after initiation of IVMP', 'description': '-To compare the differences in visual acuity (logMAR) change after standard and reduced-dose orbital radiotherapy'}, {'measure': 'Visual field (VF)', 'timeFrame': '6 months after initiation of IVMP', 'description': "\\- To compare the differences of Humphrey's visual field (mean deviation) change after standard and reduced-dose orbital radiotherapy"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiation therapy'], 'conditions': ['Thyroid Associated Ophthalmopathy']}, 'referencesModule': {'references': [{'pmid': '35662442', 'type': 'RESULT', '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.'}, {'pmid': '29942184', 'type': 'RESULT', 'citation': "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': '34297684', 'type': 'RESULT', 'citation': "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': '1802923', 'type': 'RESULT', 'citation': "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': '32140081', 'type': 'RESULT', 'citation': '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': '33012142', 'type': 'RESULT', 'citation': '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': '33860819', 'type': 'RESULT', 'citation': "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': '19865824', 'type': 'RESULT', 'citation': "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': '10634372', 'type': 'RESULT', 'citation': "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': '31496266', 'type': 'RESULT', '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."}, {'pmid': '31893319', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nPrimary 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.\n\nRadiation 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.\n\nThis 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.", 'detailedDescription': '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).\n\nThe 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.\n\nBy 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with active moderate to severe thyroid eye disease with a CAS \\> 4 with/ without diplopia before starting IVMP\n* Patient with poor response to 3 doses of IVMP (CAS drop \\< 1) หรือ CAS score \\> 3 after 3 doses of IVMP\n* Patients with diplopia after 3 doses of IVMP\n* Patients with Graves' Ophthalmopathy who have maintained euthyroidism\n* Non-pregnant adults (aged 35 years or older)\n\nExclusion Criteria:\n\n* Individuals with severe hypertension or diabetic retinopathy"}, 'identificationModule': {'nctId': 'NCT06392906', 'briefTitle': "Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)", 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': "Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)", 'orgStudyIdInfo': {'id': 'SI208/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 week external beam radiation therapy', 'description': '10 Gy in 5 fractions of external beam radiation therapy', 'interventionNames': ['Radiation: Short course radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 week external beam radiation therapy', 'description': '20 Gy in 10 fractions of standard fraction external beam radiation therapy', 'interventionNames': ['Radiation: Standard course radiation therapy']}], 'interventions': [{'name': 'Short course radiation therapy', 'type': 'RADIATION', 'otherNames': ['10 Gy in 5 fractions of radiation therapy'], 'description': '5 daily radiation treatments', 'armGroupLabels': ['1 week external beam radiation therapy']}, {'name': 'Standard course radiation therapy', 'type': 'RADIATION', 'otherNames': ['20 Gy in 10 fractions of radiation therapy'], 'description': '10 daily radiation treatments', 'armGroupLabels': ['2 week external beam radiation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok Noi', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Janjira Petsuksiri, M.D.', 'role': 'CONTACT', 'email': 'janjira.pet@mahidol.ac.th', 'phone': '66919966662'}, {'name': 'Wajana Thaweerat, M.D.', 'role': 'CONTACT', 'email': 'wajana.thaweerat@gmail.com', 'phone': '66941499212'}], 'facility': 'Faculty of Medicine Siriraj Hospital Mahidol University', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}], 'centralContacts': [{'name': 'Janjira Petsuksiri, M.D.', 'role': 'CONTACT', 'email': 'janjira.pet@mahidol.ac.th', 'phone': '66919966662'}, {'name': 'Wajana Thaweerat, M.D.', 'role': 'CONTACT', 'email': 'wajana.thaweerat@gmail.com', 'phone': '66941499212'}], 'overallOfficials': [{'name': 'Janjira Petsuksiri, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'April 15 2024- April 15 2028', 'ipdSharing': 'YES', 'description': 'Individual Participant Data (IPD) may include sensitive information about participants, such as medical history or demographic details, particularly regarding their quality of life. Sharing IPD will be conducted in accordance with Siriraj Institutional Review Board (IRB) regulations for personal data protection."', 'accessCriteria': "* Require researchers to demonstrate that their request for access to IPD has received ethical approval from Siriraj institution's Institutional Review Board (IRB).\n* 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.\n* 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.\n* 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.\n* Consider requests from researchers interested in collaborating on future research projects or initiatives related to the research topic or dataset."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janjira Petsuksiri', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Janjira Petsuksiri', 'investigatorAffiliation': 'Mahidol University'}}}}