NCT03320421已完成不适用
Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- acute radiation induced dermatitis by CTCAE within 3 months
研究概览
简要总结
This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.
详细描述
OBJECTIVES:
Primary:
To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery.
Secondary:
To determine the short term cosmetic and quality of life of the participants treated with this regimen.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female, aged between 18-70
- •pathological confirmed breast invasive carcinoma
- •patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy
- •stage p T 1-2 N 0
- •metastasis omitted by routine examinations in 1 months before enrollment
- •complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count > 1.8 *10^9/L, hemoglobin > 8.0g/dl, platelet > 75 * 10^9/L
- •hepatic and renal function in 2 weeks prior to study entry should be normal
- •study entry within 60 days from whichever comes later: surgery or last chemotherapy
- •women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry
- •signs study specific informed consent prior to study entry
排除标准
- •breast cancer with stage III/III (AJCC 7th)
- •occult breast cancer
- •in-situ breast carcinoma
- •bilateral breast cancer
- •male breast cancer
- •breast lymphoma or breast sarcoma
- •combined with Paget's disease
- •received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy
- •positive surgical margin
- •axillary lymph nodes dissection or sentinel lymph node biopsy omitted
- •regional lymph nodes radiation needed
- •boost volume larger than 1/4 of the whole breast
- •tumor bed unable to recognize on CT
- •prior invasive malignant tumor history
- •prior radiation to thoracic
- •connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc.
- •severe, active co-morbidity, defined as follows:
- •unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •severe, acute bacterial or fungal infection within the last 2 weeks
- •chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days
- •pregnant women
研究组 & 干预措施
SIB group
Experimental
Radiation therapy:
daily 5 days per week for 3 weeks. 43.5 Gy in 15 fractions to the whole breast 49.5 Gy in 15 fractions to the tumor bed boost
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
acute radiation induced dermatitis by CTCAE within 3 months
时间窗: 3 months
radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.
次要结局
- breast cosmetic result as measured by Harvard scale of breast cosmesis (excellent, good, fair, poor) every 3 months for 1year(every 3 months for 1year)
- quality of life as measured by Functional Assessment of Cancer Therapy-Breast Scale (FACT-B) every 3 months for 1 year(every 3 months for 1 year)
- in-breast recurrence rate at 1 year of radiation completion(1 year)
- late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation(3 months to 1 year)
- quality of life as measured by Breast Cancer Treatment Outcome Scale(BCTOS) every 3 months for 1 year(every 3 months for 1 year)
研究者
Yu Tang
Doctor
Chinese Academy of Medical Sciences
研究点 (1)
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