NCT00611624已完成不适用
A Phase II Trial of Mammosite Breast Brachytherapy Optimization in the Treatment of Stage 0, I and II Breast Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
研究概览
简要总结
The purpose of this study is to determine if Mammosite Catheter optimization using multiple dwell position delivery decreases skin toxicity over historically reported skin toxicity with the single dwell delivery method.
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
- •The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
- •Patient must be > 50 years old.
- •The patient should have a life expectancy of at least two years.
- •The patient must have stage 0 , I , or II breast cancer. If stage IIA, the tumor size must be 3 cm or less and the patients must be node negative.
- •On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- •Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
- •Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
- •Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is NOT required for patients with DCIS.)
- •The patient must have the MammoSite catheter placed within 4 weeks or 28 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). Placement of a spacer for the MammoSite catheter is permitted at their final surgery.
- •Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible.
- •Chemotherapy is permitted if planned for >2 weeks after removal of Mammosite catheter.
- •Patient must be ineligible or have refused enrollment on the randomized trial RTOG (Radiation Therapy Oncology Group) 0413.
排除标准
- •Men are not eligible for this study.
- •T2 (>3.0 cm), T3, node positive, stage III or IV breast cancer.
- •Any positive axillary nodes.
- •Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
- •Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Proven multicentric carcinoma in more than one quadrant or separated by more than 3 centimeters.
- •Paget's disease of the nipple.
- •History of invasive breast cancer or DCIS in the same breast.
- •Surgical margins that cannot be microscopically assessed or are less then 2 mm.
- •Collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
- •Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
- •Patients with coexisting medical conditions in whom life expectancy is < 2 years.
- •Patients with skin involvement, regardless of tumor size.
- •Patients for whom treatment with the MammoSite catheter is not feasible, such as those with too little breast tissue between the skin and the catheter (as determined by distance of dose calculations).
结局指标
主要结局
Skin Toxicity the First Year Following Treatment With the Multiple Dwell Mammosite Delivery Method.
时间窗: one year
Evaluation of skin toxicity the first year following treatment with the multiple dwell Mammosite delivery method. The number of participants with a grade 2 skin toxicity (or higher) at 1 year follow up are reported. Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC) Late Radiation Morbidity Scoring Schema were used to assess toxicity.
次要结局
- Information of Treatment Parameters in Order to Define Parameters Most Predictive of Skin Toxicity(Upon completion of study)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated RadiotherapyBreast CancerNCT01185145Rocky Mountain Cancer Centers291
已完成
2 期
Partial Breast Irradiation With Multi-Catheter Brachytherapy for pT1-2pN0 Breast Cancer After Breast Conserving SurgeryBreast CancerNCT00392184University of Erlangen-Nürnberg Medical School274
已完成
不适用
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®Ductal Carcinoma in SituBreast CancerNCT01448447Mercy Research20
Unknown
2 期
Accelerated Partial Breast Irradiation With 3D-CRT and IMRTRadiation ToxicitySide EffectsBreast CancerNCT02003560National Institute of Oncology, Hungary90
已完成
1 期
A Prototype Tri-modal Imaging Device for Breast CancerBreast Cancer Invasive NosPrimary Invasive Breast CancerNCT02794064University Health Network, Toronto5