Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM

Memorial Sloan Kettering Cancer Center7 个研究点分布在 1 个国家目标入组 40 人2021年8月11日

适应症Metastatic Cancer

干预措施Palliative radiotherapy

概览

阶段: 2 期
干预措施: Palliative radiotherapy
疾病 / 适应症: Metastatic Cancer
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 40
试验地点: 7
主要终点: Treatment failure rate of irradiated lesion
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年8月11日

结束日期

2027年8月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Memorial Sloan Kettering Cancer Center

责任方

Sponsor

入排标准

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).

干预措施: Palliative radiotherapy

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