After Mapping Of The Axilla: Radiotherapy Or Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,813
- 试验地点
- 29
- 主要终点
- Axillary recurrence rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
详细描述
OBJECTIVES:
- Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
- Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
- Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
- Compare the morbidity of patients treated with these regimens.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.
- Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
- Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer
- •Diagnosis by excisional tumorectomy allowed
- •Clinically occult invasive disease must be histologically confirmed
- •Only 1 tumor in 1 breast
- •Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI
- •Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
- •Multicentric (i.e., in different quadrants) breast cancer is not allowed
- •Clinically negative axillary lymph nodes
- •No metastatic disease
- •No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to axilla
- •No prior surgery to axilla
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
axillary lymph node dissection
complete axillary lymph node dissection
干预措施: axillary lymph node dissection (Procedure)
axillary lymph node dissection
complete axillary lymph node dissection
干预措施: lymphoscintigraphy (Procedure)
axillary lymph node dissection
complete axillary lymph node dissection
干预措施: therapeutic conventional surgery (Procedure)
axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
干预措施: therapeutic conventional surgery (Procedure)
axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
干预措施: radiation therapy (Radiation)
axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
干预措施: lymphoscintigraphy (Procedure)
结局指标
主要结局
Axillary recurrence rate
时间窗: from randomization
次要结局
- Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery(from randomization)
- Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery(from randomization)
- Axillary recurrence-free survival(from randomization)
- Disease-free survival(from randomization)
- Overall survival(from randomization)