ArthritisCancerBones and jointsRadiationPhase 1
What this study is
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
What's being tested
- Low dose radiation therapy
Intervention · RADIATION
0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)
Study details
- Official title
- Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)
- Sponsor
- University of Chicago
- Conditions
- Arthritis · Arthropathy
- Enrolling
- 20 people
- Starts
- 2026-08-26
- Est. completion
- 2028-09-17
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which they are receiving single agent or combination immunotherapy or within the last 6 months.
- Rheumatologist-established diagnosis of new onset CTCAE grade 2-3 immunotherapy-induced inflammatory arthritis or activated osteoarthritis, involving one or more joints (up to 3) including but not limited to hands, shoulders, elbows, hips, knees and ankles.
- Age ≥ 40 years.
- ECOG performance status ≤2 (Karnofsky ≥60%).
- Patients with ability and willingness to sign consent.
You can't join if
- Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was >1 year prior to consent and/or clear documentation states that the patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment.
- Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.
- History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.
- Estimated life expectancy less than 3 months as assessed by investigators.
- Any condition at the discretion of investigator that will preclude participation in the study.
- History of secondary malignancy as assessed by investigators.
- History of radiation to affected joints as assessed by investigators.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openThe University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
- Clinical Trials Intake · Contact855-702-8222cancerclinicaltrials@bsd.uchicago.edu
- Pankti Reid · Principal investigator
Study team
Sponsor
University of Chicago
Study ID IRB25-1455
Principal investigator
Pankti Reid
University of Chicago
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.