Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Acute Radiation Toxicity (CTCAE)
研究概览
简要总结
This prospective study systematically evaluates toxicity outcomes in breast cancer patients treated with adjuvant radiotherapy using the simultaneous integrated boost (SIB) technique after breast-conserving surgery. The aim is to monitor acute and late treatment-related side effects during implementation of this radiotherapy approach and to compare institutional toxicity outcomes with published data in the literature.
详细描述
Breast cancer patients undergoing breast-conserving surgery are treated with adjuvant radiotherapy using either standard fractionation or hypofractionation combined with a simultaneous integrated boost (SIB) to the tumor bed. This prospective study includes systematic collection and grading of acute and late radiation-related toxicity outcomes in order to evaluate the safety of the implemented protocol and to assess whether toxicity rates are comparable to those reported in published clinical studies. The results will support optimization and quality assurance of the radiotherapy technique in routine clinical practice.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with histologically confirmed breast cancer
- •Status post breast-conserving surgery (lumpectomy)
- •Planned adjuvant whole-breast radiotherapy with simultaneous integrated boost (SIB) to the tumor bed
- •Age ≥ 18 years
- •Ability to provide informed consent
排除标准
- •Prior radiotherapy to the breast or thoracic region
- •Mastectomy (no breast-conserving surgery)
- •Pregnancy or breastfeeding
- •Inability to complete planned radiotherapy or follow-up assessments
研究组 & 干预措施
Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB)
Breast cancer patients treated with breast-conserving surgery receive adjuvant radiotherapy to the whole breast with a simultaneous integrated boost (SIB) to the tumor bed, using either standard fractionation or hypofractionation. Acute and late toxicity outcomes are prospectively recorded.
干预措施: Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB) (Radiation)
结局指标
主要结局
Acute Radiation Toxicity (CTCAE)
时间窗: From start of radiotherapy up to 3 months after completion of radiotherapy
Incidence and severity of acute radiotherapy-related toxicity assessed during treatment and shortly after completion, graded according to Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
未报告次要终点