A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- cardiac toxicity event free survival
研究概览
简要总结
This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.
详细描述
With the development of modern radiotherapy techniques, the dose-volume of heart irradiated could be kept in much low level. However, until now, the optimal dose-volume parameters for limiting heart irradiation, the optimal follow-up interval for cardiac safety after adjuvant radiotherapy, the optimal screening examinations and treatments for irradiation-induced cardiac toxicity are unclear. We designed this trial to find answer for above questions to establish rationalization proposal for prevention, treatment and follow-up for cardiac toxicity associated with adjuvant radiotherapy for breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to participate the research and sign the informed consent file;
- •Patients aged 18-80 years;
- •Pathological diagnosis for invasive breast cancer;
- •Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy;
- •No functional heart disease;
- •LVEF≥50%;
- •Patients received breast conserving surgery;
- •Patients received modified radical mastectomy: T1-2 with N1-3 or T3-4 with any N;
- •Tumor margin negative;
- •No metastases;
- •No other malignant tumor history.
排除标准
- •Patients with metastases;
- •Tumor margin positive;
- •Patients received modified radical mastectomy with T1-2 and N0;
- •Patients have other malignant tumor;
- •Patients have a history of heart disease;
- •Patients received chest radiotherapy previously;
- •Patients with severe organic and functional disease;
- •Unqualified patients with sufficient reasons;
- •Cannot or no willing to sign the informed consent file;
- •Patients with autoimmune disease;
- •Women with pregnancy, planned pregnancy or lactating.
结局指标
主要结局
cardiac toxicity event free survival
时间窗: 1 year
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
次要结局
- overall survival(10 years)
- relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP)(1 year)
- relative change of value of serum cardiac biomarkers of CK-MB(5 years)
- relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB(1 year)
- relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I(1 year)
- Quality of Life-EORTC QLQ-C30(5 years)
- relative change of value of serum cardiac biomarkers of cTn-I(5 years)
- relative change of left ventricular ejection fraction (LVEF)(1 year)
- Quality of Life-EORTC QLQ-BR23(5 years)
- cardiac toxicity event free survival(10 years)
- relative change of value of serum cardiac biomarkers of NT-proBNP(5 years)
- relative change of LVEF(10 year)
研究者
Jiayi Chen
Chief of department of radiation oncology
Ruijin Hospital