Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 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 is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.
详细描述
During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with invasive or non-invasive breast cancer;
- •The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
- •Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
- •No distant metastasis;
- •Life expectancy ≥6 months;
- •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
- •Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
- •Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
- •Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
- •Concurrent active connective tissue disease;
- •Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
- •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).
- •Pregnant or breast-feeding.
结局指标
主要结局
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
时间窗: until 12 weeks from the completion of postoperative radiotherapy
The investigators 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; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.
次要结局
- Local regional recurrence rate(Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.)
- Disease-free survival(Until at least 5 years after diagnosis.)
- The cosmetic outcome.(The cosmetic outcome will be evaluated before and at 12, 24 and 60 months after radiotherapy.)
- Local recurrence rate(Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.)
- Overall survival(Until at least 5 years after diagnosis.)
- Quality of Life.(The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy.)
- The rate of patients who develop radiation-associated long-term toxicity(From 12 weeks to 5 years post radiotherapy.)
研究者
HAO JING
Clinical Associate Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences