NCT00165256已完成2 期
Wide Excision Alone for DCIS-Grades 1 and 2
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- To determine if patients with DCIS can be effectively treated with wide excision alone.
研究概览
简要总结
The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.
详细描述
- Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.
- Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients must have high quality mammogram including magnification views of the area containing suspicious calcifications.
- •A specimen radiograph is required. If the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required.
- •The clinical extent of DCIS must be less than or equal to 2.5 cm.
- •Grade 1 or 2 DCIS; patients with lobular carcinoma-in-situ (LCIS) in addition to DCIS in the breast are eligible. Negative margins are not required on the LCIS.
- •Patients must undergo a wide excision. A re-excision after the initial biopsy might be needed. Complete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved.
- •Patients must be enrolled on this protocol within 3 months of the last surgical procedure.
排除标准
- •Patients with invasive carcinoma including microinvasive disease
- •Carcinoma found in the sampled lymph nodes if axillary dissection is done
- •Patients with nipple discharge
- •Patients with adjuvant chemotherapy or Tamoxifen
- •Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- •Patients with a history of ipsilateral or contralateral breast carcinoma or DCIS or simultaneous bilateral DCIS.
研究组 & 干预措施
Observation (omission of RT)
Experimental
Wide excision of DCIS; no radiotherapy (RT).
干预措施: Observation (Other)
结局指标
主要结局
To determine if patients with DCIS can be effectively treated with wide excision alone.
时间窗: TBD-survivorship
Using information gathered from follow-up physical examinations and mammography to check for recurrence (DCIS or invasive carcinoma in the breast), DCIS patients treated with wide excision alone will be evaluated.
次要结局
- To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.(TBD-survivorship)
研究者
Julia S. Wong, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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