A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 6
- 主要终点
- Change in Quality of life
研究概览
简要总结
This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease.
SECONDARY OBJECTIVES:
I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed malignancy
- •Clinical or pathologic evidence of metastatic disease
- •A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis
- •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- •Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted
- •Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease)
- •Participants with known brain metastases
- •Pregnant or nursing female participants
- •Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage
- •Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site
- •Severe, active co-morbidity defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
- •Transmural myocardial infarction within the last 3 months;
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Unwilling or unable to follow protocol requirements
- •Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Change in Quality of life
时间窗: Baseline up to 12 weeks
Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance.
Pain responses
时间窗: Baseline up to 12 weeks
Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance.
次要结局
- Overall survival(Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks)