NCT01646346已完成不适用
A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer
适应症
干预措施
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
- Patients With Reduction in Incidental Radiation
研究概览
简要总结
The Purpose of this study is to evaluate the feasibility of using image guidance and four-dimensional computed tomography to reduce the volume of non target breast tissue that is treated with accelerated partial breast irradiation via the external beam technique.
详细描述
This is a pilot study enrolling about 30 patients to evaluate the feasibility of using 4D CT and daily image guidance in Accelerated Partial Breast Irradiation (APBI) to decrease set-up error and individualized planning target volumes to limit the non-target breast tissue dose. The two specific breasts constraints which shall be decreased are the V50 (percent volume of breast receiving 50% of the prescribed dose) and the V100 (percent volume of breast receiving 100% of the prescribed dose). The goal will be to decrease these to 45% and 23.5% respectively, which is down 33% from the NSABP B39 standard of 60% and 35%.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.
- •Patient must be > 50 years old.
- •The patient should have a life expectancy of at least two years with a karnofsky performance status >
- •The patient must have stage 0 or I breast cancer.
- •On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- •Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
- •Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.)
- •Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS.
- •The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
- •Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- •Chemotherapy is permitted if planned for ≥ 2 weeks after radiation.
- •Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy.
- •Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed.
- •The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less.
排除标准
- •Men are not eligible for this study as men are not breast conservation candidates.
- •T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.
- •Any positive axillary nodes.
- •Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
- •Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.
- •Paget's disease of the nipple.
- •History of invasive breast cancer or DCIS in the same breast.
- •Surgical margins that cannot be microscopically assessed or are less then 2 mm.
- •Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
- •Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.
- •Patients with coexisting medical conditions in whom life expectancy is < 2 years.
- •Patients with skin involvement, regardless of tumor size.
研究组 & 干预措施
4D Conformal Image-Guided Partial Breast RT
Experimental
This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.
干预措施: 4D Conformal Image-Guided Partial Breast RT (Radiation)
结局指标
主要结局
Patients With Reduction in Incidental Radiation
时间窗: 5 day
Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.
次要结局
- Cosmesis by Patient Report(3 year post treatment)
- Cosmesis by Medical Doctor Report(3 yr post treatment)
- Cosmesis by Patient Report(Within no more than 8 weeks of surgery, but prior to the start of radiation)
- Cosmesis by Patient Report(1 year post treatment)
- Cosmesis by Medical Doctor Report(Within no more than 8 weeks of surgery, but prior to the start of radiation)
- Cosmesis by Medical Doctor Report(1 yr post treatment)
研究者
研究点 (1)
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