Prospective Comparative Study of Hypofractionated Adjuvant Radiotherapy in 2 Virsus 3 Weeks in Breast Cancer
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Salwa Shawky Bakeet Ali
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Disease free survival analyzed from the date of diagnosis.
概览
简要总结
To compare the efficacy and safety of two hypofractionated adjuvant radiotherapy regimens 34 Gy in 10
fractions versus 40.05 Gy in 15 fractions in patients with breast cancer treated at the South Egypt Cancer
Institute.
详细描述
Female breast cancer (BC) has been the leading cause of cancer morbidity and mortality among women in the
majority of countries for decades. In 2020, there were an estimated 2.3 million new cases and 685,000 deaths
from female BC worldwide, which accounted for one in four cancer cases and one in six cancer deaths among
women.
u For women with newly diagnosed, non-metastatic breast cancer, treatment consists of a multidisciplinary
approach that involves input from surgery, radiation oncology, and medical oncology. The objective of adjuvant
radiation therapy (RT) is to eradicate any tumor deposits remaining following surgery for patients treated by
either breast-conserving surgery or mastectomy . Doing so reduces risk of locoregional recurrence and improves
breast cancer-specific and overall survivals.
u A historical regimen of 25-28 fractions over 6 weeks was adopted for radiotherapy (RT) following breast-
conserving surgery (BCS) and total mastectomy. An early assumption that breast cancer cell lines might be more
sensitive to fractional doses than acute skin reactions and other squamous carcinomas lead to development of the
hypofractionated RT (HypoRT) approach, which elevated fractional dose up to 3 Gy with reduced total
dose/fractions, for obtaining radiobiological equivalence to a traditional regimen of 50-50.4 Gy in 25-28
fractions.
u Recently, the American Society of Radiation Oncology released a task force guideline recommending
hypofractionated radiotherapy for all women of any age whether they had received chemotherapy or not ,Their
evidence-based recommendations were supported by studies from Canada and the United Kingdom.
u Benefits of HypoRT include both, radiobiologic advantages and reduced length of treatment courses, for
improving healthcare resources and patient convenience. Consequently, HypoRT has been widely adopted
worldwide based on a series of randomized clinical trials .
u Recently, HypoRT over 3 weeks and with shorter courses of 5 fractions have been recommended in treatment
guidelines.
u Regarding clinical outcomes of a 2-week fractionation schedule , it was observed that acute and late effects were
acceptable with control rates similar to those reported in other trials with hypofractionation,Based
on these findings we started a trial to compare a 3-week radiotherapy schedule with a 2-week schedule .
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years.
- •Female or male patients with invasive carcinoma of the breast.
- •Complete microscopic excision of primary tumor.
- •Undergoing breast-conserving surgery (BCS) or modified radical mastectomy (MRM).
- •≥ Axillary lymph nodes dissected.
- •T1\_4pN0\_3M0 disease.
- •Neoadjuvant or adjuvant CTH .
- •Signed informed consent and able to comply with follow up.
排除标准
- •Evidence of distant metastases.
- •Past history of malignancy.
- •Prior radiotherapy to the chest region
- •Simultaneous malignancy (except non-melanoma skin cancer or in situ cervical carcinoma)
- •Connective tissue diseases (e.g., lupus erythematosus, scleroderma)
- •Pregnancy or lactation
结局指标
主要结局
Disease free survival analyzed from the date of diagnosis.
时间窗: through study completion, an average of 1 year
local control was defined as absence of disease in the irradiated areas.recurrence were categorized as local(breast or surgical bed), regional(lymphatic drainage of axillary, supraclavicular fossa or internal mammary chain),or distant (metastasis),and any associayion of these
次要结局
- Assessment of Acute Skin Toxicity(From start of radiotherapy through 3 months after completion of radiotherapy)
- Assessment of Late Skin Toxicity(From 3 months after completion of radiotherapy through study completion, an average of 1 year)
研究者
Salwa Shawky Bakeet Ali
assiut
Assiut University