NCT05896865招募中不适用
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 5-year disease-free survival
研究概览
简要总结
The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.
The main questions it aims to answer are:
- 5-year disease-free survival
- 5-year overall survival
- 5-year locoregional recurrence
- Adverse events after radiation therapy
- Quality of life
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
- Disease status evaluation including physical and radiological examination
- Quality of life assessment with questionnaires (BREAST-Q)
- Adverse event assessment according to CTCAE version 5.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with age 19 or older
- •Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy
- •Underwent neoadjuvant chemotherapy
- •Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy
- •Eastern Cooperative Oncology Group performance status 0-2
- •Informed consent
排除标准
- •Previous history of radiation therapy to the chest
- •Distant metastasis
结局指标
主要结局
5-year disease-free survival
时间窗: 5 years from the initiation of the radiation therapy
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
次要结局
- Quality of life (BREAST-Q™)(5 years from the initiation of the radiation therapy)
- 5-year overall survival(5 years from the initiation of the radiation therapy)
- 5-year locoregional recurrence(5 years from the initiation of the radiation therapy)
- Adverse events(5 years from the initiation of the radiation therapy)
研究者
Haeyoung Kim
Associate professor
Samsung Medical Center
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity ProbabilityBreast CancerNCT06382818Institut du Cancer de Montpellier - Val d'Aurelle854
终止
不适用
OPTimizing Irradiation Through Molecular Assesment of Lymph Node After Primary Systemic TreatmentBreast CancerNCT03972696Grupo de Investigación Clínica en Oncología Radioterapia32
进行中（未招募）
不适用
Prone Breast Radiotherapy Treatment Planning Observational StudyBreast Cancer FemaleNCT02237469Vincent Vinh-Hung280
已完成
不适用
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3DBreast Cancer FemaleAdjuvant RadiotherapyNCT03801850Centre Paul Strauss60
招募中
不适用
Potential Benefits of Radiotherapy in Prone Position for Breast Cancer Patients: a Planning StudyBreast NeoplasmsRadiationNCT01284153Universitaire Ziekenhuizen KU Leuven30