Prospective Phase II Randomized Clinical Study of the Accuracy of Multi-modal Guided Particle Radiotherapy for Postoperative Breast Cancer With Different Arm Position
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The accuracy of multi-modal guided particle radiotherapy for postoperative breast cancer with different immobilization position
研究概览
简要总结
The optical body surface image (C-RAD) was used to guide and track the change of positions, and multimodal images (including 2D X-ray images, CT images and PET-CT images) were used to verify the treatment positions. In order to explore the accuracy of breast cancer patients' treatment positions and its impact on dose of the new fixation device in two different fixed positions of arm up and arm down, optimize the position fixed equipment and methods of particle radiotherapy for breast cancer, and then establish the precision process of particle radiotherapy for breast cancer under the guidance of multimodal images. In a word, this is a dosimetry and prospective Phase II randomized clinical study of the accuracy of multi-modal guided particle radiotherapy for postoperative breast cancer with different arm position.
详细描述
PET-CT: Positron Emission Tomography - Computed Tomography CT: Computed Tomography
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
- •Patients with pathologically (cytological or histological) confirmed breast cancer with positive lymph nodes and postoperative adjuvant radiotherapy
- •Exclude distant metastasis
- •No ipsilateral breast and breast radiation therapy
- •Exclude patients requiring axillary irradiation
- •Age 18-80 years old
- •General good health (Eastern Cooperative Oncology Group, ECOG 0-2)
- •No complications such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, or severe chronic heart disease that may affect radiotherapy.
- •Non-pregnant (confirmed by serum or urine β-HCG test) or lactating women
- •Patients must sign informed consent to receive radiotherapy.
排除标准
- •Pathology unapproved breast cancer
- •With distant metastasis
- •The ipsilateral breast or breast has received radiation therapy
- •Patients requiring axillary irradiation
- •The dose limit of organs at risk cannot reach the preset safe dose limit
- •Pregnancy (confirmed by serum or urine β-HCG test) or lactation
- •Poor general health, Karnofsky Performance Status (KPS)<70，or ECOG>2
- •Severe complications that may affect radiotherapy, including: a) Unstable angina pectoris, congestive heart failure, myocardial infarction requiring hospitalization in the past 6 months, b) acute bacterial or systemic fungal infection, c) hospitalization for exacerbations of chronic obstructive pulmonary disease (COPD) or other respiratory diseases
- •Unable to understand the purpose of treatment or unwilling to sign the treatment consent
结局指标
主要结局
The accuracy of multi-modal guided particle radiotherapy for postoperative breast cancer with different immobilization position
时间窗: within 3 months after radiotherapy
The optical body surface image (C-RAD) was used to guide and track the change of positions, and multimodal images (including 2D X-ray images, CT images and PET-CT images) were used to verify the treatment positions. In order to explore the accuracy of breast cancer patients' treatment positions and its impact on dose of the new fixation device in two different fixed positions of arm up and arm down, optimize the position fixed equipment and methods of particle radiotherapy for breast cancer, and then establish the precision process of particle radiotherapy for breast cancer under the guidance of multimodal images.
次要结局
- Acute toxicities(within 3 months after radiotherapy)
- Overall survival rate(at 5 years post radiotherapy)
- Tumor local control rate(at 5 years post radiotherapy)
- Progression free survival rate(at 5 years post radiotherapy)
- Late toxicities(> 3 months after radiotherapy)
研究者
Qing Zhang,MD
Professor
Shanghai Proton and Heavy Ion Center