NCT03324802已完成3 期
A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 107
- 试验地点
- 6
- 主要终点
- Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor
研究概览
简要总结
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
详细描述
PRIMARY OBJECTIVES:
I. To determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost.
SECONDARY OBJECTIVES:
I. To evaluate acute and late toxicity. II. To estimate the 5-year locoregional control, invasive disease-free survival and overall survival.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of breast cancer
- •Pathologic stage T0-T3N0-N1M0
- •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
- •Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable)
- •Able to complete all mandatory tests
- •Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- •Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale
- •Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
- •Breast conserving surgery and indications for whole breast radiotherapy
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, 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
- •Pregnancy
- •Prior receipt of ipsilateral breast or chest wall radiation
- •Positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
- •History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
- •Recurrent breast cancer
- •Indications for comprehensive regional nodal irradiation
结局指标
主要结局
Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor
时间窗: 24 months
The complication rate will be reported by arm.
次要结局
- Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs)(3 months)
- Number of Patients Experiencing Grade 3+ Late Adverse Events(24 months)
- Percent of Patients With Locoregional Recurrence(5 years)
- Number of Patients Experiencing Distant Recurrence(5 years)
- Invasive Disease-free(5 years)
- Cause-specific Survival(1 year)
- Overall Survival(1 year)
- Disease-Free Survival(5 years)
研究者
研究点 (6)
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