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北京协和医学院Hypofractionated Online Adaptive Radiotherapy of Breast Cancer II期 40 适应性设计
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06568705旨在研究治疗，主要针对乳腺癌。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2024年9月1日，计划招募40名患者。该研究由北京协和医学院主导，预计于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月20日。
简要概括
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:
- Can online adaptive radiotherapy improve the accuracy of dose delivery?
- In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities ...
详细描述
Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body positio...显示更多
官方标题
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
疾病
乳腺癌其他研究标识符
- HF_BCoART
NCT编号
实际开始日期
2024-09-01
最近更新发布
2026-03-20
预计完成日期
2026-12
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
关键词
Online Adaptive Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性26Gy/5f online adaptive radiotherapy The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy. | Ultrafractionated Radiation Treatment The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy. |
阳性对照43.5Gy/15f online adaptive radiotherapy The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy. | Moderate hypofractionated Radiation Treatment The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The dose coverage of target volume as assessed by planning tumor volume V100% | Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume. | 3 months after radiotherapy |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Treatment-related toxicity | Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0. | Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy. |
Local recurrence rate (LRR) | LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse. | 3, 6, 12, 24 months after radiotherapy |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
35 Years
适龄性别
女性
- Female, aged ≥35 years, <70 years
- ECOG score: 0-2
- Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
- Pathologically confirmed primary breast cancer
- For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
- Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
- Able to cooperate and tolerate the treatment
- Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
- History of radiotherapy to the neck or chest
- Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
- History of malignant tumors
北京协和医学院482 个活跃的临床试验可供探索研究中心联系人
联系人: Xiaorong Hou, MD, +86-13811963013, [email protected]
联系人: Xiaorong Hou, +86-13811963013, [email protected]
1 位于 1 个国家/地区的研究中心
Peking Union Medical College Hospital, Beijing, China
Xiaorong Hou, MD, 联系人, +86-13811963013, [email protected]
招募中