A Prospective Study of Preoperative MRI Linac-based Tumor-bed Boost Followed by Breast-conservative Oncoplastic Surgery and Adjuvant Ultra-hypofractionated Whole Breast Radiotherapy for Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
研究概览
简要总结
This study explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients less than 55 years old, who are diagnosed with breast cancer and are eligible to recieve breast-conserving surgery are enrolled. Patients who are older than 55 years, with suspected regional lymph node metastasis are excluded. The primary end point are the acute toxicities within 4 weeks after adjuvant radiation. The secondary endpoints are oncologic outcomes, surgical complications within 30 days, late toxicities, patients' quality of life and cosmetic outcomes.
详细描述
This is a prospective, non-controlled, feasitility study. The tumor-bed boost part of the radiotherpay is put forward, 7-14 days before the definitive surgery. A single dose of 10Gy is prescribed to the tumor bed. In order to identify the tumor accurately, MRI guided radiotherapy is applied under the MR-linac. The breast surgery is planned after recovery from radiation induced acute toxicity, within 14 days. The surgeons would undertake lumpectomy only or an additional oncoplastic surgery, with axillary nodal evaluation with sentinal nodal biopsy or dissection. After wound healing, postoperative whole breast radiotherapy is administered, within 6 weeks following surgery. The dose is 26Gy/5.2Gy/5 fractions. Adjuvant systemic therapy is held until the end of the radiotherapy, no more than 12 weeks from surgery implementation.
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
- — 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with invasive breast cancer;
- •cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0;
- •Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery;
- •No distant metastasis;
- •The primary tumour> 5mm from the skin, without invasion of the ribs or intercostal muscles;
- •No neoadjuvant systemic therapy;
- •Patients who can tolerate MRI;
- •Life expectancy ≥5 years;
- •Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
- •Patients are willing to cooperate to follow up;
- •Patients should sign the informed consent;
- •Women of childbearing age need effective contraception.
排除标准
- •Concurrent active connective tissue disease;
- •Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;
- •Other malignancies, which affect pateint life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1));
- •Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
结局指标
主要结局
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
时间窗: until 4 weeks of postoperative radiotherapy
We will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin. The incidence of all the above is the primary outcome.
次要结局
- Disease-free survival(Until 5 years after diagnosis.)
- Complications of surgery in the short term.(Until 30 days after the surgery.)
- Local recurrence rate(Until 5 years after diagnosis.)
- Overall survival(Until 5 years after diagnosis.)
- Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC BR-23(Until 5 years after treatment.)
- Cosmetic outcome Body Image Scale (BIS)(Until 5 years after treatment.)
- Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS)(Until 5 years after treatment.)
- Local regional recurrence rate(Until 5 years after diagnosis.)
- Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC QLQ-C30(Until 5 years after treatment.)
研究者
HAO JING
professor of medicine
Cancer Institute and Hospital, Chinese Academy of Medical Sciences