NCT00104702已完成2 期
Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- Reproducibility
研究概览
简要总结
RATIONALE: 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 trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer.
Secondary
- Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients.
- Determine relapse-free survival of patients treated with this regimen.
- Determine overall and specific survival of patients treated with this regimen.
- Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients.
- Determine the direct and indirect costs of this regimen in these patients.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of invasive breast cancer
- •Stage I or II disease
- •Tumor size ≤ 30 mm
- •Located in any breast quadrant
- •No nodal involvement
- •No inflammatory breast cancer
- •No positive margins after surgical resection (performed on study)
- •No microcalcifications
- •Hormone receptor status
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Not specified
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Concentrated and Focalized Radiotherapy
Experimental
干预措施: adjuvant therapy (Procedure)
Concentrated and Focalized Radiotherapy
Experimental
干预措施: conventional surgery (Procedure)
Concentrated and Focalized Radiotherapy
Experimental
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Reproducibility
时间窗: 1 month
次要结局
- Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score(3 weeks)
- Relapse-free survival(1 year)
- Overall and specific survival(1 year)
- Cosmetic result(1 year)
- Direct and indirect costs(1 month)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast CancerBreast CancerNCT00527293Case Comprehensive Cancer Center29
已完成
3 期
Radiation Therapy After Surgery in Treating Women With Early Stage Breast CancerBreast CancerNCT00005588Medical Research Council
已完成
2 期
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving SurgeryBreast CancerNCT01082211Radiation Therapy Oncology Group65
已完成
3 期
Radiation Therapy After Surgery in Treating Women With Early Stage Breast CancerBreast CancerNCT00005587Medical Research Council
已完成
不适用
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast CancerLong-term Effects Secondary to Cancer Therapy in AdultsSkin Reactions Secondary to Radiation TherapyBreast CancerNCT00599989Abramson Cancer Center at Penn Medicine28