NCT00556777已完成不适用
Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer
Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2004年4月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.
详细描述
OBJECTIVES:
Primary
- Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer.
Secondary
- Study the impact of this regimen on maintaining self-care.
- Study the quality of life (QLQ-C30) and satisfaction with care.
- Study regimen tolerance and cosmetic results.
- Evaluate the economic impact of this treatment.
- Study relapse-free and disease-specific survival.
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
- 65 Years 至 120 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Histologically confirmed stage I breast cancer
- •Size ≤ 20 mm (by ultrasound), N0, any quadrant
- •Hormone receptor status not specified
排除标准
- •Distant metastases
- •Inflammatory breast cancer
- •Lobular in situ disease
- •Invasive cancer or ductal carcinoma in situ
- •Nonepithelial disease or sarcoma
- •Multicentric disease
- •Lymphatic embolism
- •Margins of safety unknown or positive (in situ or invasive)
- •Preoperative mammography showing diffuse microcalcification
- •PATIENT CHARACTERISTICS:
- •Menopausal
- •Karnofsky 70-100%
- •No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years
- •No geographic, social, or psychiatric reasons that would impede participation in study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior neoadjuvant therapy
- •No concurrent participation in another study
结局指标
主要结局
Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
时间窗: During the treatment of irradiation (4 weeks)
feasibility based on dosimetric criteria based on the Quality Index of the application.
Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
时间窗: During the treatment of irradiation (4 weeks)
reproducibility based on dosimetric criteria based on the Quality Index of the application.
次要结局
- impact on Quality of life of partial irradiation of the breast by per-operative electron therapy(from the baseline to 12 months after the treatment)
- Tolerability of partial irradiation of the breast by per-operative electron therapy(from the baseline to 12 months after the treatment)
- Relapse-free survival(from the baseline to 12 months after the treatment)
- Disease-specific survival(from the baseline to 12 months after the treatment)
研究者
研究点 (2)
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