A Phase Ⅲ Randomized Clinical Study and Real World Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 3,142
- 试验地点
- 1
- 主要终点
- tumor-free survival rate
研究概览
简要总结
The research hypothesis is that the tumor-free survival rate of intermediate-risk breast cancer patients exempted from RNI is not inferior to that of those receiving RNI. Patients with intermediate-risk breast cancer have a relatively low local-regional recurrence rate whether they undergo RNI or not.Patients were randomly assigned to the RNI group and the non-RNI group.After radiotherapy,the patients are followed the efficacy and toxicities of radiotherapy are evaluated.
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
- •Female patients aged 18 or above
- •Undergo breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy
- •The surgical margin was negative
- •Tumor stage:Patients who receive direct surgery : pT1-2N1M0, with at least one lymph node having macrometastasis and a tumor risk score of 0-2.For those who underwent surgery after neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0 (cN+ with pathological confirmation), neoadjuvant Chemotherapy for ≥6 cycles.
排除标准
- •distant metastasis
- •metastasis of ipsilateral internal mammary, supraclavicular or subclavian lymph nodes
- •Had received chest radiotherapy in the past
- •Bilateral breast cancer
- •Pregnancy or lactation period
- •Other malignant tumors in the past or at the same time, and the tumor-free survival time is less than 5 years (excluding non-malignant melanoma skin cancer, papillary thyroid carcinoma/follicular carcinoma, cervical carcinoma in situ)
研究组 & 干预措施
Regional nodal irradiation
woman with intermediate-risk Breast Cancer involve postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
干预措施: Regional nodal Radiotherapy (Radiation)
Non-Regional nodal irradiation
woman with intermediate-risk Breast Cancer receive conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.
干预措施: Non-Regional nodal Radiotherapy (Radiation)
结局指标
主要结局
tumor-free survival rate
时间窗: 5 year
次要结局
- localregional recurrence(5 year)
- overall survival(5 year)
- acute toxicity(6 months)
- late complication(5 year)
研究者
Shulian Wang,MD
M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences