NCT00699101终止4 期
A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- SenoRx, Inc.
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.
研究概览
简要总结
This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.
详细描述
Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.
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
- All
- 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 or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
- •sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
- •axillary dissection (minimum of six 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 ≤ 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 (if appropriate, patient must use birth control during the study)
- •Active collagen-vascular disease
- •Paget's disease of the breast
- •History of DCIS or invasive breast cancer
- •Prior breast or thoracic RT 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 or close
- •Positive axillary node(s)
- •T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
- •Estrogen receptor negative tumor
结局指标
主要结局
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.
时间窗: 5 years
次要结局
- Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.(5 years)
研究者
研究点 (2)
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