RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- ≥Grade 2 acute radiation-induced toxicity
研究概览
简要总结
The purpose of this trial is to establish a feasible DVH estimation model of integrated IMRT plan for HF-RNI with Eclipse™ Treatment Planning System and a Varian RapidPlan™ model based on the above DVH constraints.
详细描述
Eligible breast cancer patients will receive hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) at the discrection of radition oncologists. CTV including breast/chest wall and regional nodes will be contoured according to RTOG contouring atlas. Integrated multi-beam IMRT plan will be generated and optimized using our predefined protocol for OAR constrains and target coverage. All integrated IMRT plans will be designed using the Eclipse™ Treatment Planning System. All these tight margin IMRT plan will be passed in pre-treatment dry run with the motion management workflow involved and the target coverage during the treatment will be confirmed. The plans which pass the above on-line verification will then be de-identified and transferred to RapidPlan configuration workspace for RNI model training and verification.All enrolled patients will be regularly followed up during and after RT. Acute and late toxicity will be documented as well as tumor control endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old
- •Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer pT1-3
- •≥1 pathologically positive axillary lymph nodes
- •Karnofsky Performance Status scoring ≥80
- •Surgery wound healed without infection
- •Anticipative overall survival >5 years
- •Pathologically surgical margin >2mm
- •ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
- •Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation
- •Ability to understand and willingness to participate the research and sign the consent form
排除标准
- •Axillary dissection of less than 10 lymph nodes
- •Pathologically positive ipsilateral supraclavicular lymph node
- •Pathologically or radiologically confirmed positive ipsilateral internal mammary lymph nodes
- •Pregnant or lactating women
- •Treated with breast reconstruction surgery
- •Severe non-neoplastic medical comorbidities
- •History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix
- •simultaneous contralateral breast cancer
- •Previous RT to the neck, chest and/or ipsilateral axillary region
- •Active collagen vascular disease
- •Definitive pathological or radiologic evidence of distant metastatic disease
- •Primary T4 tumor
- •Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks
结局指标
主要结局
≥Grade 2 acute radiation-induced toxicity
时间窗: 6 months
Within time from beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicity will be assessed every week during radiotherapy, 4 weeks, 3 months and 6 months after the last fraction received using the (Common Terminology Criteria for Adverse Events) CTCAE 3.0 and recorded.
次要结局
- ≥Grade 2 Late Radiation-induced Toxicity(5 years)
- Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale(5 years)
- Quality of Life-EORTC QLQ-C30 and QLQ-BR23(5 years)
- Locoregional recurrence (LRR)(5 years)
- distant metastasis free survival (DMFS)(5 years)
- overall survival (OS)(5 years)
- invasive recurrence free survival (IRFI)(5 years)
研究者
JIAYI CHEN
Chief of Department of Radiation Oncology
Ruijin Hospital