Ultra-hypofractionated Radiotherapy for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Acute Radiation Toxicity
研究概览
简要总结
Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.
The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.
详细描述
Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.
If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).
The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).
A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- Breast-conserving surgery
- Invasive ductal carcinoma
- Age ≥ 50
- Tumor size ≤ 3 cm
- R0 resection
- Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
- pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
- Hormone receptor status - any
- Histological grade G1 or G2
排除标准
- Neoadjuvant systemic therapy
- TNBC (triple-negative breast cancer)
- Extensive intraductal component (EIC)
- Lymphovascular invasion (LVI)
- associated DCIS > 2.5 cm in size or high nuclear grade
研究组 & 干预措施
Partial Breast Irradiation
干预措施: Partial Breast Irradiation (Radiation)
Whole Breast Irradiation
干预措施: Ultra-hypofractionated WBI (Radiation)
结局指标
主要结局
Acute Radiation Toxicity
时间窗: From the start of radiotherapy up to 6 months.
Proportion of participants experiencing acute radiation toxicity, defined as toxicity occurring within 6 months of the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
Late Radiation Toxicity
时间窗: From 6 months after the start of radiotherapy up to 60 months.
Proportion of participants experiencing late radiation toxicity, defined as toxicity occurring more than 6 months after the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
Acute toxicity
时间窗: 1-6 months after RT
Assessment of acute toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
Late toxicity
时间窗: 6-60 months after RT
Assessment of late toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
次要结局
- Time to Local-Regional Recurrence(From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.)
- Disease-Free Survival (DFS)(From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.)
- Overall Survival (OS)(From adjuvant radiotherapy until death from any cause, assessed up to 10 years.)
- Time to Distant Metastasis(From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.)
- Physician-reported Harvard Breast Cosmesis Scale(Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.)
- Patient-reported Harvard Breast Cosmesis Scale(Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.)
- Quality of Life - EORTC QLQ-C30 (Serbian version)(Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.)
- Quality of Life - EORTC QLQ-BR23 (Serbian version)(Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.)
- Overall Survival(3, 5 and 10 years)
- Cosmetic outcome(at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.)
- Local-regional control(3, 5 and 10 years)
- Distant metastasis occurrence(3, 5 and 10 years)
- QoL assessment(at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.)
- Disease-free survival(3, 5 and 10 years)
研究者
Marko Bojovic
Principal Investigator
Oncology Institute of Vojvodina
研究点 (2)
标识符
- NCT 编号
- NCT05914831
- 其他研究编号
- NS-dojka-SRB
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (4个月前)
- 研究完成日期
- (9年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
The analyzed data from the study will be published in scientific journals. We are prepared to share our data for analysis with researchers from similar studies (previously registered on ClinicalTrials.gov) to compare our results.