NCT02054689已完成不适用
PHASE I STUDY OF FRACTIONATED STEREOTACTIC RADIOSURGERY FOR LARGE BRAIN METASTASES
Steven Burton2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Patients Experiencing DLT
研究概览
简要总结
This is a research trial that seeks to break up the total radiation dose into multiple smaller radiation treatments, termed fractionated stereotactic radiosurgery (FSRS) which may make the treatment feasible. Fractionated sterotatcic radiation, the risks of FSRS, and possible costs will be described later in this document. This clinical trial is for people who have had no prior whole brain radiation.
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
- •Male or female patients ≥ 18 years of age
- •A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70 (Appendix II)
- •The target lesion(s) can be accurately measured in at least one dimension according to RECIST
- •No prior radiotherapy to the brain
- •Previous or concurrent systemic or targeted chemotherapy is allowed
- •Patients must have an extra-cranial primary tumor diagnosis
- •Patients will have no more than 3 distinct lesions within the brain. At least 1 lesion must be a minimum of 3cm in greatest dimension, no larger than 5cm which will be treatable by fractionated stereotactic radiosurgery
- •The additional lesions will each be treated with single fraction stereotactic radiosurgery
- •Patient may be on steroids or anti-epileptics
- •Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
- •Patients do not need a histologically proven diagnosis of brain mets
排除标准
- •Symptomatic patients in need of surgery to the "target" lesion
- •Four or more newly-diagnosed lesions
- •Prior surgical resection of targeted tumor
- •Prior WBRT
- •Primary brain tumor
- •Pregnant or breast-feeding patients
- •Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor
结局指标
主要结局
Number of Patients Experiencing DLT
时间窗: Up to 3 years
The number of patients experiencing DLT, defined as the maximum amount of Gy fractionated stereotactic radiosurgery (FSRS) delivered without significant toxicity.
Maximum Tolerated Dose (MTD)
时间窗: Up to 24 months post completion of treatment
The MTD was determined following a Time-to-Event Continual Reassessment Model which models toxicity as a function of dose. Treatment was given in 3 fractions (8-12 Gy/fx).
次要结局
- Best Response(Up to 24 months after completion of treatment)
- Local Control of Disease(Up to 24 months after completion of treatment)
- Regional Intracranial Failure(Up to 24 months after completion of treatment)
- Functional Assessment of Cancer Therapy - Brain (FACT-Br)(Prior to treatment; 30 days post treatment; 8 -12 weeks, 22-28 weeks, 30-42 weeks, 45-60 weeks, 64-74 weeks, 80-84 weeks, 90-96 weeks,100-112 weeks, 120-124 weeks, 130-140 weeks, 145-155 weeks, and 160-170 weeks post treatment)
研究者
Steven Burton
Clinical Associate Professor
University of Pittsburgh
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Stereotactic Radiation Therapy in Treating Patients With Advanced Liver CancerLiver CancerNCT00607828University of Nebraska7
已完成
1 期
Stereotactic Radiation, Nelfinavir Mesylate & Neoadjuvant Chemotherapy in Locally Advanced Pancreatic CancerAdenocarcinoma of the PancreasStage III Pancreatic CancerNCT01068327University of Nebraska46
已完成
1 期
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung CancerNon-small Cell Lung CancerNCT00888823AHS Cancer Control Alberta13
已完成
1 期
Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar CancersAdvanced Cervical AdenocarcinomaAdvanced Vaginal CarcinomaAdvanced Vulvar CarcinomaHuman Papillomavirus-Related Cervical Squamous Cell CarcinomaHuman Papillomavirus-Related Vulvar Squamous Cell CarcinomaMetastatic Cervical AdenocarcinomaMetastatic Cervical CarcinomaMetastatic Cervical Squamous Cell Carcinoma, Not Otherwise SpecifiedMetastatic Vaginal AdenocarcinomaMetastatic Vaginal CarcinomaMetastatic Vulvar CarcinomaRecurrent Cervical AdenocarcinomaRecurrent Cervical CarcinomaRecurrent Cervical Squamous Cell Carcinoma, Not Otherwise SpecifiedRecurrent Vaginal CarcinomaRecurrent Vulvar CarcinomaStage III Cervical Cancer AJCC v8Stage III Vaginal Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Vulvar Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Vulvar Cancer AJCC v8Stage IIIC Vulvar Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Vaginal Cancer AJCC v8Stage IV Vulvar Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Vaginal Cancer AJCC v8Stage IVA Vulvar Cancer AJCC v8Stage IVB Cervical Cancer AJCC v8Stage IVB Vaginal Cancer AJCC v8Stage IVB Vulvar Cancer AJCC v8Vaginal Squamous Cell Carcinoma, Not Otherwise SpecifiedVulvar AdenocarcinomaVulvar Squamous Cell CarcinomaNCT03452332M.D. Anderson Cancer Center20
已完成
2 期
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain MetastasesBrain MetastasesNCT02654106Chinese Academy of Medical Sciences65