Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

Официальное название

A Feasibility Study of Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)

Обзор

The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.

Вмешательства

• Лучевая терапия simulation-free, single-fraction palliative radiation therapy
  Radiation will be delivered in a single fraction. The recommended prescription dose is 8 Gy with external beam radiation therapy.

Первичные конечные точки

• To assess the rate at which the intervention is delivered with fidelity to protocol. [Срок оценки: 1 day]

Вторичные конечные точки (1)

• The percentage of patients who experience an improved Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain score at 30 days post-treatment compared to baseline. [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Participant aged ≥ 18 years.
• Diagnosis of any cancer with one to two painful and treatable metastatic bone lesions.
• Bone metastases are causing pain or instability in the opinion of the treating investigator.
• Amenable to single fraction radiation therapy per the discretion of the treating physician.
• CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
• ECOG Performance Status ≤ 2.
• Participants must adhere to the following sex and contraceptive/barrier requirements:

• If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy test are available for review before treatment.
• For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

• < 50 years of age:

• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
• Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution

---≥ 50 years of age:

• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
• Had radiation-induced menopause with last menses >1 year ago; or
• Had chemotherapy-induced menopause with last menses >1 year ago
• Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Критерии исключения

• Evidence of spinal cord compression caused by the bone metastases to be treated.
• Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• Participants taking prohibited medications as described in Section 6.7.1.

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

• Huntsman Cancer Institute/University of Utah — Salt Lake City

Идентификаторы

NCT: NCT07202273 · HCI193478

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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