A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,611
- 试验地点
- 156
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.
详细描述
OBJECTIVES:
- Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative.
- Compare the effect of these two regimens on the overall and disease-free survival of these patients.
- Compare the morbidity associated with these two regimens in these patients.
- Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology.
- Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology.
- Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons.
- Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients.
Objectives of quality of life questionnaire in sentinel node-negative patients:
- Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens.
- Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side.
- Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
干预措施: conventional surgery (Procedure)
Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
干预措施: Sentinel node resection followed by node examination (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 8 years
Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
Morbidity - Number of Participants With Residual Arm Tingling
时间窗: before and after surgery (within 30 days of randomization)
Morbidity as measured by residual arm tingling
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit
时间窗: Before and after surgery (within 30 days of randomization)
Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.
Morbidity - Number of Participants With Residual Arm Numbness
时间窗: before and after surgery (within 30 days of randomization)
Morbidity as measured by residual arm numbness
Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.
时间窗: 8 years
Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
Morbidity - Number of Participants With Residual Arm Volume Difference
时间窗: before and after surgery (within 30 days of randomization)
Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery
次要结局
- The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.(At time of surgery (within 30 days of randomization))
- Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.(At time of surgery (within 30 days of randomization))
- Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence(From the time of randomization until 5 years)