NCT07274800已完成不适用
Adjuvant Ultra Hypofractionation Radiotherapy Versus Hypofractionation Radiotherapy in Treatment of Early Invasive Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acute Skin Toxicity (CTCAE v5.0)
研究概览
简要总结
breast-conserving surgery. One group receives ultra-hypofractionated radiotherapy (26 Gy in 5 sessions over 1 week), while the other group receives hypofractionated radiotherapy (40 Gy in 15 sessions over 3 weeks). The study aims to compare skin toxicity, cosmetic outcomes, and local cancer control between thetwo schedules . Participants are followed during and after radiotherapy for up to 24 months.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of breast adenocarcinoma
- •Prior breast conservative surgery negative resection margins (3 mm)
- •Pathological stage pT1-pT2, N0-1, pT3-N0, M0
- •No macroscopic evidence of distant metastases at diagnosis
- •Age 18-80 years
- •Female patients
- •Normal hematological and biochemical laboratory tests
- •Written informed consent was obtained from all patients
排除标准
- •Patients underwent mastectomy.
- •Locally advanced disease pT4, N2,
- •Positive surgical margins
- •Prior thoracic radiation
- •Synchronous second primary tumor
- •Distant metastases
- •Pregnancy
- •Presence of a concomitant psychiatric disorder precluding an aware informed consent.
- •Age >80 years
- •Low risk patient meeting all the following criteria (more than or equal 65 years, PT1, grade 1 or 2, +ER, -Her2nu, N0, M0).
结局指标
主要结局
Acute Skin Toxicity (CTCAE v5.0)
时间窗: From start of radiotherapy to 6 weeks post-treatment
Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed
次要结局
- Late Skin Toxicity and Cosmesis(12 months post-radiotherapy)
- Locoregional Recurrence(Up to 24 months post-radiotherapy)
研究者
研究点 (1)
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