Randomized Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage invasive breast cancer after CBS. This prospective randomized clinical trial aims to evaluate the outcomes of one-week and once weekly schedules of WBI against the investigator's standard hypofractionated WBI ( 40 Gy /15 fraction /3 weeks) in females with early stage breast cancer after CBS.
详细描述
- Radiotherapy Timing If the patient is not receiving chemotherapy, WBI is to be initiated within 9 weeks following lumpectomy or re-excision of margins. For patients receiving chemotherapy, WBI is to begin no fewer than 2 weeks and no more than 8 weeks after the last cycle of chemotherapy.
- Randomization:
138 patients will be randomized using permuted blocks randomization to 3 equal comparable arms.
- Dose Prescriptions
Arm 1:
One week WBI: 27Gy/5 fractions /1 week. 5.4 Gy/fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Tis, pT1-2, pN0-1, M0 disease
- •Invasive carcinoma of the breast or ductal carcinoma insitu [DCIS]
- •CBS (reconstruction is not allowed)
- •Negative surgical margin
- •Axillary staging &/or dissection
排除标准
- •pT3-4, pN2-3 breast cancer
- •Inadequate axillary lymph node dissection
- •Neoadjuvant chemotherapy
- •Non-epithelial breast malignancies such as sarcoma or lymphoma
- •Synchronous bilateral invasive or non-invasive breast cancer
- •History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
- •Past history of malignancy except
- •Basal cell skin cancer
- •CIN cervix uteri
- •Cosmetic breast implants (Patients who have had implants removed are eligible.)
- •Prior breast or thoracic RT for any condition
- •Collagen vascular disease, specifically systemic lupus, or scleroderma
- •Pregnancy or lactation at the time of radiotherapy. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
研究组 & 干预措施
One week Whole Breast Irradiation
WBI: 27 Gy/5 fractions/1 week. 5.4 Gy /fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.
干预措施: Whole Breast Irradiation (Other)
Once weekly Whole Breast Irradiation
WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week.
干预措施: Whole Breast Irradiation (Other)
3 weeks Whole Breast Irradiation
WBI: 40.05 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI
干预措施: Whole Breast Irradiation (Other)
结局指标
主要结局
Acute toxicity
时间窗: 3 months from the start of whole breast irradiation
The proportion of patients with grade ≥3 toxicity according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria.
Ibsilateral locoregional tumor control
时间窗: Annually after the end of whole breast irradiation for 5 years.
must be confirmed by cytological/ histological assessment
patient-reported outcome measures (PROMs)
时间窗: Annually after the end of whole breast irradiation for 5 years.
measured by The European Organisation for Research and Treatment of Cancer, EORTC Quality of Life questionnaire for breast cancer patients ( EORTC QLQ-BR 23).
Cosmetic outcome
时间窗: Annually after the end of whole breast irradiation for 5 years
measured by The European Organisation for Research and Treatment of Cancer (EORTC) breast cosmetic rating system (observer rating)
次要结局
- Overall survival(5 years from the initial diagnosis of breast cancer)
- late toxicity(Annually after the end of whole breast irradiation for 5 years.)
- Distant disease-free survival(5 years from the initial diagnosis of breast cancer)