MRI-Guided Stereotactic Body Radiotherapy for the Treatment of Early Stage Kidney Cancer: A Single Arm Phase II Clinical Trial (MRI-MARK)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
This phase II trial investigates how well MRI-guided stereotactic body radiation therapy works in treating patients with early-stage kidney cancer. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. This method of radiation delivery is further refined through the incorporation of a MRI into the radiation machine to create a device known as a MRI linear accelerator. During treatment with MRI linear accelerator, continuous MRI images are obtained to allow for real-time treatment monitoring and the ability to adjust treatment plans if minor deviations in anatomy are noted. Giving MRI-guided stereotactic body radiation therapy may help treat patients with early-stage kidney cancer.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate local control following magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) for primary kidney cancer as defined by no growth by imaging at 24 months following SBRT.
SECONDARY OBJECTIVES:
I. To estimate preservation of renal function and to determine frequency of grade 3+ adverse events following SBRT as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
II. To characterize tumor and treated kidney changes by multiparametric MRI, including utility of diffusion and perfusion changes in renal cell carcinoma (RCC) prior to and after SBRT as biomarkers of treatment response.
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
- •Patients may enter the study if they are diagnosed with bilateral kidney cancer, multiple lesions in the same kidney, recurrent kidney cancer, or if they have previous or current history of a separate cancer, given all other inclusion criteria met
- •Have a pathologically confirmed diagnosis of renal cell carcinoma (RCC) of any histology
- •Be a suboptimal surgical or ablation candidate, as determined by patient's primary urologist at MD Anderson Cancer Center and by multi-disciplinary consensus. At or before the time of enrollment, a note documenting multidisciplinary consensus supporting active treatment will be recorded in the patient's chart
- •Tumor stage of T1-T2a (i.e. 10cm or less in greatest dimension)
- •Be technically and anatomically appropriate for MRI-guided SBRT, as determined by patient's primary radiation oncologist. Factors considered will include distance between tumor and bowel, tumor movement with respiration as assessed by 4-dimensional (4D) computed tomography (CT) scan, and prior radiotherapy
- •Multi-disciplinary consensus that active treatment is warranted
- •Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Have life expectancy of 2 years or more
排除标准
- •An MRI contraindication (i.e. pacemaker, severe claustrophobia, or MRI-incompatible device)
- •A pre-treatment estimated glomerular filtration rate < 30 cc/min
- •Visceral, nodal, or bony metastatic disease
- •Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit
- •Female subject of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation
- •Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
结局指标
主要结局
Time to progression
时间窗: at 24 months
Local control will be defined as no growth (stability or regression) in the largest dimension of the treated tumor by comparison of magnetic resonance imaging (MRI) images at baseline and 24 months following completion of stereotactic body radiation therapy (SBRT). The local control rate will be compared to case-matched data from patients undergoing active surveillance at MD Anderson Cancer Center. In terms of the primary efficacy analysis, the local control will be evaluated along with the 95% confidence interval. For patients who progress earlier than 24 months will be considered as local control failure and will be included in the confidence interval calculation. In addition, we will estimate the probabilities of local control utilizing the Kaplan Meier method with corresponding 95% confidence intervals.
次要结局
- Treatment related toxicities(Up to 24 months after completion of SBRT)
- Preservation of renal function(Baseline to 24 months)
- Changes in the imaging of primary tumor and treated kidney(Baseline up to 24 months after completion of SBRT)
- Pathologic response(At 24 months)
- Progression free survival(At 24 months)
- Economic strain of MRI-guided SBRT(Baseline to 24 months)
- Distant metastasis-free survival(Up to 24 months)
- Overall survival(Up to 24 months)
- Planned doses(up to 1 month)
- Correlation of normal tissue true delivered doses with grade 3+ toxicity(Up to 24 months after completion of SBRT)
- Rate of cases in which the prescribed isodose line failed to cover 100% of the internal gross tumor volume (iGTV)(Up to 24 months after completion of SBRT)