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

December 1, 2024 updated by: Janjira Petsuksiri

Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Individuals with severe hypertension or diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 week external beam radiation therapy
10 Gy in 5 fractions of external beam radiation therapy
Radiation: Short course radiation therapy
5 daily radiation treatments
Other Names:
  • 10 Gy in 5 fractions of radiation therapy
Active Comparator: 2 week external beam radiation therapy
20 Gy in 10 fractions of standard fraction external beam radiation therapy
Radiation: Standard course radiation therapy
10 daily radiation treatments
Other Names:
  • 20 Gy in 10 fractions of radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Activity Score (CAS) change
Time Frame: 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.
6 months after initiation of IVMP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle and retrobulbar fat volume change
Time Frame: 6 months after initiation of IVMP
To compare the change in volume of extra-ocular muscles and retro bulbar fat after orbital radiotherapy, comparing standard with reduced-dose orbital radiotherapy
6 months after initiation of IVMP
change in diplopia
Time Frame: 6 months after initiation of IVMP
To compare the difference in prism deviation in primary gaze after standard and reduced-dose orbital radiotherapy
6 months after initiation of IVMP
change in quality of life
Time Frame: 6 months after initiation of IVMP
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.
6 months after initiation of IVMP
Radiation toxicities
Time Frame: 6 months after initiation of IVMP
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.
6 months after initiation of IVMP
Visual acuity (VA)
Time Frame: 6 months after initiation of IVMP
-To compare the differences in visual acuity (logMAR) change after standard and reduced-dose orbital radiotherapy
6 months after initiation of IVMP
Visual field (VF)
Time Frame: 6 months after initiation of IVMP
- To compare the differences of Humphrey's visual field (mean deviation) change after standard and reduced-dose orbital radiotherapy
6 months after initiation of IVMP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janjira Petsuksiri

Collaborators

Mahidol University

Investigators

  • Principal Investigator: Janjira Petsuksiri, M.D., Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 1, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI208/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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."

IPD Sharing Time Frame

April 15 2024- April 15 2028

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Associated Ophthalmopathy

Clinical Trials on Short course radiation therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe