Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.
详细描述
OBJECTIVES:
- Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy.
- Compare local regional control in patients treated with these regimens.
- Assess the potential toxic effects of radiotherapy in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0)
- •Primary tumor no greater than 5 cm
- •At least 1 but no more than 3 positive axillary lymph nodes
- •Nodes cannot be positive solely by cytokeratin staining
- •No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast
- •No bilateral breast cancer
- •No active local regional disease
- •Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months
- •Surgical margins negative for invasive and noninvasive ductal carcinoma
- •No gross extracapsular disease or residual disease in the axilla
- •Microscopic extracapsular extension allowed
- •No mastectomy after local failure following lumpectomy
- •Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •21 and over
- •Menopausal status:
- •Pre- or post-menopausal
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No serious medical or psychiatric illness that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior trastuzumab (Herceptin)
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 6 weeks since prior adjuvant chemotherapy
- •No other prior chemotherapy
- •Concurrent adjuvant chemotherapy allowed
- •Endocrine therapy:
- •See Disease Characteristics
- •Concurrent adjuvant hormonal therapy allowed
- •Radiotherapy:
- •No prior chest wall or nodal radiotherapy
- •See Disease Characteristics
- •Breast reconstruction allowed
- •Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed
排除标准
- 未提供
研究组 & 干预措施
surgery
surgery followed by observation
干预措施: surgery (Procedure)
surgery followed by RT
Surgery followed by radiation therapy
干预措施: radiation therapy (Radiation)
surgery followed by RT
Surgery followed by radiation therapy
干预措施: surgery (Procedure)