Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- detection of irregularity of breast shape
研究概览
简要总结
Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule.
The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.
详细描述
Operational Design Patient Assessment Pre-radiotherapy assessment is done to provide a baseline for use in further follow-up and to rule out metastasis. This includes detailed history taking, full physical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.
Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Setup, simulation and target definition For setup, patients were positioned on a wingboard with both arms raised above the head and radiopaque markers along breast borders. Subsequently, the 5-mm slice-thick axial CT images were acquired from the lower mandible aspect to 5 cm below contralateral inframammary fold. The CT images will be automatically transferred to a planning workstation, where the CTV and relevant organs-at-risk (OARs) will be outlined. The planning of the tangential fields will be based on the target volume delineation for the dose-volume distribution analysis. The heart and ipsilateral lung were separately contoured as organs at risk, the heart was outlined to the pulmonary trunk superiorly, including pericardium and excluding major vessels. For setup verification purposes, weekly digitally reconstructed radiographs (DRRs) were performed.
Evaluation of Treatment Follow-up is done for assessment of toxicity and disease-free and overall survival.
During follow-up, patients are examined after completion of radiotherapy and at 3 and 6 months. Surveillance includes a full clinical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.
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 modified radical mastectomy
- •negative resection margins (3 mm)
- •pathological stage pT1-pT2, N0-2 (AJCC, 2017)
- •no macroscopic evidence of distant metastases at diagnosis
- •Age 18-80 years
- •Normal hematological and biochemical laboratory tests
- •Written informed consent was obtained from all patients
排除标准
- •locally advanced disease pT3-pT4, N3
- •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
结局指标
主要结局
detection of irregularity of breast shape
时间窗: 6 months after radiotherapy
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
detection of breast shrinkage
时间窗: 6 months after radiotherapy
breast size measured before and after radiotharapy
breast on the treated side is indurated
时间窗: 6 months after radiotherapy
the induration detected by palpation with comparison with the normal side
次要结局
未报告次要终点
研究者
Rawda Ahmed Abdul Hakim Balata
Dr
Zagazig University