A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,832
- 试验地点
- 26
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.
详细描述
OBJECTIVES:
- Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients (in certain participating centers) treated with these regimens.
- Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (<10, > or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised*, and participating center. Patients are randomized to one of two treatment arms.
NOTE: * Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed
- Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
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
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven invasive carcinoma of the breast
- •No evidence of T4, N2-3, or M1 disease prior to surgery
- •Node positive or high-risk node negative
- •Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT
- •Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision
- •Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site
- •Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria
- •If node positive, then a level I and II axillary dissection must be performed
- •No evidence of residual disease in axilla after dissection
- •Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy
- •High risk of regional and systemic recurrence due to one of the following:
- •Pathologically positive axillary lymph nodes
- •Pathologically negative axillary lymph nodes with one of the following:
- •Primary tumor greater than 5 cm
- •Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:
- •Estrogen receptor negative
- •Skarf-Bloom-Richardson grade 3
- •Lymphovascular invasion
- •Hormone receptor status:
- •Estrogen and progesterone receptor status known
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Menopausal status:
- •Premenopausal or postmenopausal
- •Performance status:
- •Life expectancy:
- •At least 5 years
- •Hematopoietic:
- •Not specified
- •SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)*
- •Alkaline phosphatase no greater than 3 times ULN* NOTE: * Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations
- •No serious nonmalignant renal disease
- •Cardiovascular:
- •No serious nonmalignant cardiovascular disease
- •No serious nonmalignant pulmonary disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy
- •No other malignancy except:
- •Nonmelanomatous skin cancer
- •Carcinoma in situ of the cervix or endometrium
- •Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)
- •Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation
- •No psychiatric or addictive disorder that would preclude informed consent or study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- 另有 7 项未显示
排除标准
- 未提供
研究组 & 干预措施
Standard Breast Irradiation
干预措施: Standard Breast Irradiation (Radiation)
Breast Radiation plus regional radiation
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
干预措施: Breast Radiation plus Regional Radiation (Radiation)
结局指标
主要结局
Overall Survival
时间窗: 10 years
Duration of study
次要结局
- Disease-free Survival(10 years)