A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- the failure rate of breast reconstruction after hypofractionated proton radiotherapy
研究概览
简要总结
The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1: Patients with pathologically confirmed breast cancer
- •2: Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction
- •3: No distant metastasis
- •4: Had no chest and breast radiotherapy history
- •5: Between the ages of 18 and 80
- •6: ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy
- •7: Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women
- •8: The patient must sign the informed consent form for receiving radiotherapy.
排除标准
- •1: No pathological confirmation；
- •2: Distant metastasis；
- •3: Had chest and breast radiotherapy history
- •4: Organs at risk could not achieve safe dose
- •5: Pregnancy (confirmed by serum or urine β- HCG test) or lactating women
- •6: Poor general health status, i.e. KPS<70, or ECOG>2
- •7: There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；
- •8: Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.
结局指标
主要结局
the failure rate of breast reconstruction after hypofractionated proton radiotherapy
时间窗: within 2 years after hypofractionated proton radiotherapy
Reoperation
次要结局
- Tumor local control rate, overall survival rate and progression free survival rate(within 5 years after radiotherapy)
- Acute and late toxicities(within 5 years after radiotherapy)
研究者
Qing Zhang,MD
Professor
Shanghai Proton and Heavy Ion Center