Radiation to Treat Joint Damage Caused by Cancer Immunotherapy

Официальное название

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

Обзор

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

Вмешательства

• Лучевая терапия 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)

Первичные конечные точки

• Radiation therapy [Срок оценки: 3 months post enrollment.]

Вторичные конечные точки (5)

• Effectiveness of Radiation in treating immunotherapy-induced arthritis. [Срок оценки: 3 months post enrollment.]
• To examine the use of steroids. [Срок оценки: 3 months post enrollment.]
• To examine the use of rescue analgesics. [Срок оценки: 3 months post enrollment.]
• Effectiveness of Radiation in treating immunotherapy-induced arthritis. [Срок оценки: 3 months post enrollment.]
• Effectiveness of Radiation in treating immunotherapy-induced arthritis. [Срок оценки: 3 months post enrollment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Chicago Medicine Comprehensive Cancer Center — Chicago

Идентификаторы

NCT: NCT07478679 · IRB25-1455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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