NCT07478679

Brief Summary

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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
25mo left

Started Aug 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 26, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 2, 2026

Last Update Submit

March 18, 2026

Conditions

ArthritisArthropathy

Keywords

RadiotherapyArthropathyImmunotherapyCancet

Outcome Measures

Primary Outcomes (1)

  • Radiation therapy

    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.

    3 months post enrollment.

Secondary Outcomes (5)

  • Effectiveness of Radiation in treating immunotherapy-induced arthritis.

    3 months post enrollment.

  • To examine the use of steroids.

    3 months post enrollment.

  • To examine the use of rescue analgesics.

    3 months post enrollment.

  • Effectiveness of Radiation in treating immunotherapy-induced arthritis.

    3 months post enrollment.

  • Effectiveness of Radiation in treating immunotherapy-induced arthritis.

    3 months post enrollment.

Study Arms (1)

Radiation treatment

EXPERIMENTAL
Radiation: Low dose radiation therapy

Interventions

Low dose radiation therapyRADIATION

0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)

Radiation treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

ArthritisJoint Diseases

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Pankti Reid

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 17, 2026

Study Start (Estimated)

August 26, 2026

Primary Completion (Estimated)

September 17, 2028

Study Completion (Estimated)

September 17, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(1)