Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- Treatment failure rate of irradiated lesion
研究概览
简要总结
This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.
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
- •Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
- •Pathogenic mutation in ATM (somatic and germline allowed)
- •ECOG performance status 0-2
- •Age ≥ 18 years.
- •Able to provide informed consent.
- •Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments.
- •Expected life expectancy of at least 6 months
排除标准
- •Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- •Serious medical co-morbidities precluding radiotherapy.
- •Pregnant or breast-feeding women.
- •Lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including CNS disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.
研究组 & 干预措施
radiation
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases). The study uses a prespecified 2-stage design with early stopping after the first stage to evaluate whether treatment-failure rates are acceptably low relative to a historical benchmark.
干预措施: Palliative radiotherapy (Radiation)
结局指标
主要结局
Treatment failure rate of irradiated lesion
时间窗: 6 month
Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST
次要结局
未报告次要终点