NCT00107497已完成不适用
Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST
Institute of Cancer Research, United Kingdom38 个研究点 分布在 1 个国家目标入组 917 人开始时间: 2004年10月5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
- 917
- 试验地点
- 38
- 主要终点
- Change in photographic breast appearance
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.
详细描述
OBJECTIVES:
- Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence.
- Compare tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
- Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks.
After completion of study treatment, patients are followed annually for 5-10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of invasive carcinoma of the breast
- •Localized disease
- •Pathological tumor size < 3.0 cm in diameter
- •Axillary node negative
- •At average or low risk of local tumor recurrence
- •Must have undergone prior breast-preserving surgery
- •No prior mastectomy
- •Complete microscopic resection of tumor
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •50 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior neoadjuvant or adjuvant cytotoxic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent lymphatic radiotherapy
- •No concurrent radiotherapy boost to the breast
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Change in photographic breast appearance
时间窗: 2 years post randomisation
Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph
次要结局
未报告次要终点
研究者
研究点 (38)
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