Clinical trial · Interventional
Radiation to Treat Joint Damage Caused by Cancer Immunotherapy
Use of Low-Dose RADiotherapy in the Management of Immune Checkpoint- Inhibitor-ArThropathy as an Immune-Related Adverse Event (RADIATE)
NCT07478679CI-TRIAL-00106256not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis | — | UNRESOLVED | — |
| Arthropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation treatment
- interventionNames
- Radiation: Low dose radiation therapy
Primary outcomes (1)
- measure
- Radiation therapy
- timeFrame
- 3 months post enrollment.
- description
- 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 (5)
- measure
- Effectiveness of Radiation in treating immunotherapy-induced arthritis.
- timeFrame
- 3 months post enrollment.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.