Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Identify the recurrence timing.
研究概览
简要总结
An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.
详细描述
PRIMARY OBJECTIVE:
I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery.
SECONDARY OBJECTIVES:
I. Identify the histological lineage of the tumor.
II. Identify the degree of differentiation of tumor cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma.
- •Treated with breast-conserving surgery and stage pT1-2 pN0 M
- •Over 18 years.
- •Patients who sign informed consent for research study.
排除标准
- •Positive nodes.
- •Clinical or pathological stage T3-T
- •History of previous irradiation.
- •Postoperative positive margin.
结局指标
主要结局
Identify the recurrence timing.
时间窗: 5 years
Quantify the time to recurrence through follow up in both groups
Identify the progression timing.
时间窗: 5 years
Quantify the time to progression through follow up in both groups
次要结局
- Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry(14 months)
- Identify the degree of differentiation of tumor cells(14 months)
- Measure the frequency of toxicity in both groups.(5 years)
- Classify toxicity according to its severity.(5 years)
- Identify the histological lineage of the tumor(14 Months)
研究者
Patricia Berenice Bolado Garcia
MD.
Coordinación de Investigación en Salud, Mexico