[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07478679":3,"trial-entities:NCT07478679":104,"trial-summary:NCT07478679":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":56,"minimum_age":57,"maximum_age":15,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":76,"locations":79,"central_contacts":98,"overall_officials":100,"references":102,"see_also_links":103},"NCT07478679","IRB25-1455","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)","NOT_YET_RECRUITING","2028-09-17","2026-03","2026-03-23","2026-08-26","University of Chicago","OTHER",null,"This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.",[18,19],"Arthritis","Arthropathy",[21,19,22,23],"Radiotherapy","Immunotherapy","Cancet","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"RADIATION","Low dose radiation therapy","0.5 Gy per treatment x 6 treatments, given 2-3 treatments per week over 2-3 weeks (Can be given concurrently with IO)",[37],"Radiation treatment",[39],{"measure":40,"description":41,"timeFrame":42},"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.",[44,47,50,52,54],{"measure":45,"description":46,"timeFrame":42},"Effectiveness of Radiation in treating immunotherapy-induced arthritis.","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\u002Fmoderate pain with signs of inflammation, erythema, or joint swelling, limiting instrumental activities of daily living (ADLs). Grade 3 represents severe pain\u002Fsevere pain with signs of inflammation, erythema, or joint swelling, irreversible joint damage, limiting instrumental activities of daily living (ADLs).",{"measure":48,"description":49,"timeFrame":42},"To examine the use of steroids.","Change in the daily use of rescue analgesics and need for steroids specifically for immunotherapy induced arthritic pain.",{"measure":51,"description":49,"timeFrame":42},"To examine the use of rescue analgesics.",{"measure":45,"description":53,"timeFrame":42},"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)",{"measure":45,"description":55,"timeFrame":42},"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.","ALL","40 Years",false,{"inclusion":60,"exclusion":66,"raw_text":75},[61,62,63,64,65],"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.",[67,68,69,70,71,72,73,74],"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\u002For 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.","Inclusion Criteria:\n\n* 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.\n* 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.\n* Age ≥ 40 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%).\n* Patients with ability and willingness to sign consent.\n\nExclusion Criteria:\n\n* Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.\n* 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\u002For 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.\n* Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.\n* History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.\n* Estimated life expectancy less than 3 months as assessed by investigators.\n* Any condition at the discretion of investigator that will preclude participation in the study.\n* History of secondary malignancy as assessed by investigators.\n* History of radiation to affected joints as assessed by investigators.",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":95},"The University of Chicago Medicine Comprehensive Cancer Center","Chicago","Illinois","60637","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Clinical Trials Intake","CONTACT","855-702-8222","cancerclinicaltrials@bsd.uchicago.edu",{"name":93,"role":94},"Pankti Reid","PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},41.85003,-87.65005,[99],{"name":88,"role":89,"phone":90,"email":91},[101],{"name":93,"affiliation":13,"role":94},[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[18,106],"Solid Neoplasm",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.","completed","Radiation for Joint Damage from Cancer Immunotherapy","This study is looking into a treatment called low dose radiation therapy (LDRT) for joint pain and damage (arthritis or arthropathy) caused by cancer immunotherapy. You might be able to join if you are 40 or older, have cancer that has spread or can't be removed, and are currently receiving immunotherapy or received it within the last six months. You also need to have a diagnosis from a rheumatologist (a doctor specializing in joint and muscle diseases) of new or worsening joint inflammation from immunotherapy. The study will give you 0.5 Gy of radiation per treatment, 6 times over 2-3 weeks. Researchers will measure how well the radiation therapy works at 3 months after you enroll. This study is currently recruiting 20 participants to see if this treatment is safe and possible.","Your response to radiation therapy will be measured at 3 months after you enroll.",132,"You would receive 6 low dose radiation treatments, given 2-3 times per week over 2-3 weeks.","Not stated in the trial record.",[34],"v2"]