A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Ductal Breast Carcinoma in Situ
- 发起方
- Case Comprehensive Cancer Center
- 试验地点
- 3
- 主要终点
- Ipsilateral breast tumor recurrence rates
- 状态
- 撤回
- 最后更新
- 14年前
概览
简要总结
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
详细描述
PRIMARY OBJECTIVES: I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates. II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation. SECONDARY OBJECTIVES: I. To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease. II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire. III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy. OUTLINE: Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ipsilateral breast tumor recurrence rates
时间窗: 5 years after completion of radiation
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
时间窗: at 1 year after radiation
次要结局
- To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy(5 years after completion of radiation treatment)
- Patient satisfaction with the procedure as determined by a questionnaire(at 1 year after radiation)
- To evaluate wound healing and overall complication rate after radiation(at one year after radiation)