Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Acute toxicity by CTCAE at 6 weeks
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer.
Secondary
- Determine the long-term cosmetic result and quality of life of patients treated with this regimen.
- Determine the long-term local control in patients treated with this regimen.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma of the breast
- •Invasive or in-situ disease
- •Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease
- •Treated with breast-conserving surgery within the past 8 weeks
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Not specified
- •Not specified
- •No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer
- •No active systemic lupus
- •No history of scleroderma
- •No other medical or psychiatric condition that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 6 weeks since prior adjuvant systemic chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to the breast
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Radiation therapy
Radiation Therapy
Daily 5 days per week for 4 weeks
45 Gy in 20 fractions whole breast
56 Gy in 20 fractions to boost volume
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Acute toxicity by CTCAE at 6 weeks
时间窗: 6 weeks
次要结局
- Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years(every 6 months for 5 years)