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纪念斯隆-凯特琳癌症中心A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change II期 40
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临床试验NCT05010031旨在研究治疗，主要针对转移性癌症。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2021年8月11日，计划招募40名患者。该研究由纪念斯隆-凯特琳癌症中心主导，预计于2027年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月23日。
简要概括
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.
官方标题
Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
疾病
转移性癌症其他研究标识符
- 21-310
NCT编号
实际开始日期
2021-08-11
最近更新发布
2026-01-23
预计完成日期
2027-08
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
关键词
Reduced-dose Radiation
Pathogenic Mutations
ATM (ataxia telangiectasia mutated)
21-310
Pathogenic Mutations
ATM (ataxia telangiectasia mutated)
21-310
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性radiation Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases). | 姑息性放射治疗 An initial cohort of 12 evaluable patients will be treated with 4Gyx2, with adaptive dosing planned for expansion cohorts pending the number of failures observed after 6 month observation of the initial cohort. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Treatment failure rate of irradiated lesion | Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST | 6 month |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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
- 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.
纪念斯隆-凯特琳癌症中心739 个活跃的临床试验可供探索研究中心联系人
联系人: Amy Xu, MD, PhD, 646-888-6863, [email protected]
联系人: Daniel Gomez, MD, 212-639-2087
7 位于 1 个国家/地区的研究中心
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 10065, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
招募中
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, 07748, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
招募中
Memorial Sloan Kettering Bergen (All protocol activities), Montvale, New Jersey, 07645, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
招募中
New York
Memorial Sloan Kettering Commack (All protocol activities), Commack, New York, 11725, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
招募中
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, 10604, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
招募中
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
Daniel Gomez, MD, 联系人, 212-639-2087
Amy Xu, MD, PhD, 主要研究者
招募中
Memorial Sloan Kettering Nassau (All protocol activities), Uniondale, New York, 11553, United States
Amy Xu, MD, PhD, 联系人, 646-888-6863
招募中