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NCT Number: NCT07478679

Radiation to Treat Joint Damage Caused by Cancer Immunotherapy

This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location contact

Clinical Trials Intake

CONTACT

[email protected]

855-702-8222

Pankti Reid

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Low Dose Radiation Therapy

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)

Primary outcomes

  1. Radiation therapy

    Time frame: 3 months post enrollment.

    To assess the safety and feasibility of administering Low dose radiation therapy (LDRT) in patients with immunotherapy-induced arthritis. Number of patients that experience at least one treatment related Common Terminology Criteria for Adverse Events (CTCAE) grade 4 or 5 side effect.

Secondary outcomes

  1. Effectiveness of Radiation in treating immunotherapy-induced arthritis.

    Time frame: 3 months post enrollment.

    To assess pain relief in patients using the Common Terminology Criteria for Adverse Events (CTCAE) v5 pain assessment. Grade 1 represents mild pain or mild pain with inflammation, erythema, or joint swelling. Grade 2 represents moderate pain/moderate pain with signs of inflammation, erythema, or joint swelling, limiting instrumental activities of daily living (ADLs). Grade 3 represents severe pain/severe pain with signs of inflammation, erythema, or joint swelling, irreversible joint damage, limiting instrumental activities of daily living (ADLs).

  2. To examine the use of steroids.

    Time frame: 3 months post enrollment.

    Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.

  3. To examine the use of rescue analgesics.

    Time frame: 3 months post enrollment.

    Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.

  4. Effectiveness of Radiation in treating immunotherapy-induced arthritis.

    Time frame: 3 months post enrollment.

    To assess pain relief in patients using the Visual Analogue Pain Scale (VAPS) score. The scale is bordered by "no pain" (score of 0) and "worst imaginable pain" (score of 10)

  5. Effectiveness of Radiation in treating immunotherapy-induced arthritis.

    Time frame: 3 months post enrollment.

    To assess pain relief in patients using the Von Pannewitz Score (VPS). The responses are rated as follows: stable (no improvement), slightly improved, markedly improved, and painless.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake

CONTACT

[email protected]

855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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