A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Local Recurrence Rate
研究概览
简要总结
PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.
详细描述
OBJECTIVES:
- Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
- Determine the survival rate in patients treated with this regimen.
METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
- •Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
- •Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
- •Must have been excised with breast-conserving resection and no positive margins
- •Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
- •No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
- •Hormone receptor status: Not specified
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over
- •Sex: Female
- •Menopausal status: Not specified
- •Performance status: Not specified
- •Life expectancy: Not specified
- •Hematopoietic: Not specified
- •Hepatic: Not specified
- •Renal: Not specified
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy: Not specified
- •Chemotherapy: Not specified
- •Endocrine therapy: Not specified
- •Radiotherapy: No prior radiotherapy to the ipsilateral breast
- •Surgery: See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Adjuvant Radiotherapy
Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
干预措施: Adjuvant Radiotherapy (Radiation)
结局指标
主要结局
Local Recurrence Rate
时间窗: 36 months after initial excision
Local recurrence rate of phyllodes tumors
次要结局
- Survival Rate(Approximately 5 years)
研究者
Richard J. Barth,Jr.
Chief, Section of General Surgery
Dartmouth-Hitchcock Medical Center