NCT00882596已完成4 期
A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
研究概览
简要总结
The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.
详细描述
The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able and willing to sign informed consent
- •Age 50 or older at diagnosis
- •Life expectancy greater than 10 years (excluding diagnosis of breast cancer)
- •Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria)
- •On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma
- •For patients with invasive breast cancer, an axillary staging procedure must be performed [either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative]
- •The T stage must be Tis, T1, or T
- •If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter
- •Estrogen receptor positive tumor
排除标准
- •Age < 50 at diagnosis (regardless of histology)
- •Pregnant or breast-feeding
- •Active collagen vascular disease
- •Paget's disease of the breast
- •Prior history of DCIS or invasive breast cancer
- •Prior breast or thoracic radiation therapy for any condition
- •Multicentric carcinoma (DCIS or invasive)
- •Synchronous bilateral invasive or non-invasive breast cancer
- •Surgical margins that cannot be microscopically assessed or that are positive
- •Positive axillary node(s)
- •T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4
- •Estrogen receptor negative tumor
结局指标
主要结局
Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
时间窗: 19 months
次要结局
- Toxicity rates(79 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157Hypertension, RenalNCT02095691Biosense Webster, Inc.19
已完成
3 期
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar StenosisLow Back PainLeg PainLumbar Spinal StenosisSpondylolisthesisNCT00405691Impliant, Ltd.450
已完成
不适用
Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real WorldGastrointestinal Stromal TumorsNCT05381753CStone Pharmaceuticals61
尚未招募
不适用
Biomarkers of Traumatic Brain Injury With Tbit SystemBrain Injuries, TraumaticNCT04107662BioDirection Inc740
Unknown
不适用
Prospective Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial InterventionsArterial EmbolizationNCT02863133Antia Therapeutics AG65