Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.
研究概览
简要总结
The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer. IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT. Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious. In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection. After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room. EBRT to the whole breast will be administered once the surgical wound has healed adequately. The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy. Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligibility:
- •Histologically proven primary invasive breast carcinoma.
- •Tumor pathologically determined <= 5cm in diameter.
- •Single, discrete, well-defined primary tumor.
- •Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
- •Pathologically negative surgical margins.
- •Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling.
- •ECOG performance status 0-
- •Contraindications:
- •Multicentric disease and/or diffuse malignant appearing microcalcifications.
- •Evidence of metastatic breast cancer.
- •Axillary lymph node involvement.
- •Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
- •Prior irradiation to the ara of planned radiation field.
- •Pregnant or lactating women.
排除标准
- 未提供
研究组 & 干预措施
Single arm study
Patients with stage T1/T2No breast cancer receiving breast conserving treatment
干预措施: Intra-operative radiation to tumor bed (Radiation)
结局指标
主要结局
Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.
时间窗: weekly evaluation during 5 weeks of radiation
To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale
Determine the local tumor control and distant tumor control rates for patients with stage T1/T2N0M0 breast cancer.
时间窗: every 6 months follow-up for 5 years, then yearly to end in 04/2013
Determine long-term side effects and cosmetic outcome of IOERT to tumor bed and EBRT after lumpectomy for patients with stage T1/T2N0Mo breast cancer.
时间窗: every 6 months follow-up for 5 years, then yearly to end in 04/2013
To determine the late skin reaction, breast edema, pneumonitis, cardiac side effects during radiation using RTOG late toxicity scale
次要结局
未报告次要终点