A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast or Post-Mastectomy Chest Wall Including Regional Nodal Irradiation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 146
- 试验地点
- 3
- 主要终点
- Complication rate
研究概览
简要总结
This phase III trial compares the rate of complications of x-ray therapy versus proton beam radiation therapy after breast conserving surgery or mastectomy in treating patients with breast cancer. X-ray therapy is a form of radiation therapy that uses high-energy radiation from x-rays to kill tumor cells and shrink tumors. Proton beam radiation therapy is a type of radiation therapy that uses high-energy beams to treat tumors. It is not yet known what level of complications x-ray therapy or proton beam radiation therapy have in treating patients with breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the 24-month complication rate of 5 fraction radiotherapy compared to 25 fraction radiotherapy.
SECONDARY OBJECTIVES:
I. To evaluate acute toxicity that occur up to 12 months after radiation. II. To evaluate late toxicity that appear or persist 12 months after radiation. III. To estimate the 5-year locoregional control, invasive disease-free survival, disease-free survival, cause-specific survival and overall survival.
CORRELATIVE AND EXPLORATORY OBJECTIVES:
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
- Single (Outcomes Assessor)
盲法说明
Panel-assessed cosmetic outcome
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Histological confirmation of breast cancer
- •Breast conserving surgery or mastectomy (reconstruction is allowed)
- •Clinical or pathologic T1-T4c, N0-3, M0 disease
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
- •Able to and provides Institutional Review Board (IRB) approved study specific written informed consent
- •Indications for breast or post mastectomy radiation with regional nodal radiotherapy per the discretion of the treating physician
- •If uncertain of eligibility please consult the principal investigator (PI)
排除标准
- •Medical contraindication to receipt of radiotherapy
- •Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator or PI, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent
- •Active systemic lupus or scleroderma
- •Prior receipt of ipsilateral breast or chest wall radiation
- •Persistent positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
- •No active metastatic disease from other origin
- •Recurrent breast cancer
- •Patient requires bilateral breast radiation treatment
- •cT4d patients (inflammatory breast cancer)
- •Patients that may not be compliant or fit for the study at the discretion of the PI
- •Male patients
研究组 & 干预措施
Arm I (x-ray therapy)
Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy.
干预措施: Questionnaire Administration (Other)
Arm I (x-ray therapy)
Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy.
干预措施: X-ray Therapy (Radiation)
Arm II (proton beam radiation therapy)
Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy.
干预措施: Proton Beam Radiation Therapy (Radiation)
Arm II (proton beam radiation therapy)
Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Complication rate
时间窗: At 24 months
Will be defined as the percentage of women evaluable at 24 months who develop one or more of these events: grade 3 or higher late adverse event or unplanned surgeries for cosmetic or treatment related events, including surgeries to remove implant.
次要结局
- Incidence of late toxicity(Up to 5 years post-radiation therapy)
- Cause-specific survival(Up to 5 years post-radiation therapy)
- Disease-free survival(Up to 5 years post-radiation therapy)
- Overall survival(Up to 5 years post-radiation therapy)
- Locoregional control(Up to 5 years post-radiation therapy)
- Invasive disease-free survival(From study registration until the time of invasive disease recurrence (not including ductal carcinoma in situ) or death due to any cause, assessed up to 5 years post-radiation therapy)
- Incidence of acute adverse events(Up to 12 months post-radiation therapy)