Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Patients With Ipsilateral Breast Tumor Recurrence
研究概览
简要总结
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.
详细描述
OBJECTIVES:
Primary
- Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite^® Radiation Therapy System.
Secondary
- Determine the early and late complication rates and cosmetic outcome in these patients after treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy
- •Size: < 3 cm on mammogram
- •Unicentric disease
- •Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy
- •Patient Age: ≥ 18 years, no upper limit
- •Life expectancy > 5 years
排除标准
- •Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix
- •Pregnant or breast feeding
- •Multicentric disease
- •Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis
研究组 & 干预措施
Lumpectomy with Brachytherapy
Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
干预措施: Tamoxifen (Drug)
Lumpectomy with Brachytherapy
Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
干预措施: Lumpectomy (Procedure)
Lumpectomy with Brachytherapy
Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
干预措施: brachytherapy (Radiation)
结局指标
主要结局
Number of Patients With Ipsilateral Breast Tumor Recurrence
时间窗: 5 years after treatment
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
次要结局
- Percentage of Patients Who Experienced Complications(more than 6 months after treatment, for up to 5 years)
- Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent(12 months after treatment)
- Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent(12 months after treatment)