A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of Participants With SABR Successfully Delivered in One Fraction
研究概览
简要总结
This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject must be ≥18 years of age at the time of study enrollment
- •Subject must have Biopsy-confirmed primary or metastatic carcinoma with involvement of the lung, liver, adrenal gland, pancreas, kidney, and/or abdominal/pelvic lymph node that would receive SABR
- •Any lesion that would receive SABR under this study protocol is no larger than 5 cm in greatest dimension
- •1-10 total lesions that would receive SABR
- •If multiple lesions are treated, they must be at least 3 cm apart
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Life expectancy at least 6 months
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it's the patient preferred method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Patients receiving hormonal therapy or immunotherapy such as immune checkpoint inhibitor that had begun at least 4 weeks prior to SABR will be allowed.
排除标准
- •Subject has contraindication to having an MRI scan
- •Subject has central or ultra-central lung tumor that would receive SABR on this study, defined as a lesion located within 2 cm of the trachea and proximal bronchial tree
- •Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
- •Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
- •Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy
- •Subject has any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results
- •Subject has received prior radiation therapy that directly overlaps any radiation therapy given in this study
- •Subject has received radiation therapy that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator
- •Female subject who are pregnant or breastfeeding
- •Subject who has received vascular endothelial growth factor (VEGF) inhibitor such as bevacizumab within 4 weeks prior to study therapy or planned to receive it within 4 weeks after study therapy.
结局指标
主要结局
Number of Participants With SABR Successfully Delivered in One Fraction
时间窗: through study completion, an average of 1 year
To be considered successful, SABR treatment must meet the following criteria: 1. Successful completion of treatment to each lesion within 3 days of intended treatment date 2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions 3. Image guidance verification of treatment delivery within 5 mm of the planned delivery
Number of Patients Demonstrating Tolerability
时间窗: through study completion, an average of 1 year
Number of patients that meet the following criteria: 1. No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR 2. No grade 5 toxicity is attributed to SABR
次要结局
- One-year Local Control(12 months)
- Percent of Participants With One-year Overall Survival(12 months)
- Number of Participants With Acute and Late Toxicity Results(12 months)
- Change in Participant Reported Quality of Life Questionnaire(baseline, 3, 6, 9, and 12 months after treatment)