Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer
Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
研究概览
详细说明
OBJECTIVES:
- To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence.
OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
- Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
- Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.
After completion of study treatment, patients are followed annually for 10 years.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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England
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Sutton、England、英国、SM2 5PT
- 招聘中
- Royal Marsden - Surrey
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接触：
- John R. Yarnold, MD, FRCR
- 电话号码：44-20-8661-3388
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
- Resectable, unilateral disease
- T1-3, N0-1, M0 disease
- Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
- Age 18-49 years
- Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
- Tumor of any size treated by primary medical therapy
- Grade III disease
- Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)
- Lymphovascular invasion
- Axillary node positive
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior mastectomy
- No concurrent chemotherapy except primary or sequential chemotherapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Arm I (control)
Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
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Given as 48, 53, or 56 Gy
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实验性的：Arm II
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
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Given as 48, 53, or 56 Gy
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实验性的：Arm III
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
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Given as 48, 53, or 56 Gy
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研究衡量的是什么？
主要结果指标
结果测量 |
|---|
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Palpable induration inside the boost volume of the irradiated breast
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次要结果测量
结果测量 |
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总生存期
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Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
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Local tumor control
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Location of tumor relapse in breast
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Contralateral primary tumors
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Regional and distant metastases
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合作者和调查者
调查人员
- 首席研究员：John R. Yarnold, MD, FRCR、Royal Marsden NHS Foundation Trust
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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