CTRI/2013/10/004041尚未招募未知
Cyberknife® partial breast irradiation for early stage breast cancer
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 or T2 less than 3 cm treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy. Patients should be node negative.
- •DCIS or invasive ductal or medullary or papillary or mucinous (colloid)or or tubular histologies.
- •The patients Karnofsky performance status (KPS) must be more than 80percent
- •Patients must be more or equal to 40 years of age.
- •If chemotherapy is planned it must begin no earlier than two weeks following completion of radiation therapy.
- •Unifocal breast cancer (no evidence of gross multifocal disease or multicentric or bilateral disease confirmed on preoperative breast MRI).
- •Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as more than 2 mm clear of tumor in all directions).
- •Negative post- lumpectomy mammography if malignancy-associated microcalcifications were initially present.
- •The target lumpectomy cavity must be clearly delineated.
- •Patients must complete appropriate pretreatment evaluation including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal.
排除标准
- •Evidence of suspicious microcalcifications in the breast prior to start of radiation.
- •Patients with history of collagen vascular disease specifically dermatomyositis with a CPK level above normal or active skin rash or systemic lupus erythematosis or scleroderma.
- •Patients with histologically positive axillary nodes.
- •Patients with distant metastases.
- •Patients with invasive or extensive insitu lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- •Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy.
- •Patients must not have any palpable or radiographically suspicious ipsilateral or contralateral axillary or supraclavicular or infraclavicular or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
- •Any previously treated contra lateral invasive breast carcinoma or synchronous contra lateral breast carcinoma.
- •Prior non-hormonal therapy or radiation therapy for the current breast cancer or hormonal therapy for more than 28 days after diagnosis or refusal to discontinue hormonal therapy.
- •Patients with Pagets disease of the nipple.
- •Patients with prior invasive malignancy except non-melanomatous skin cancer unless disease free for a minimum of 3 years like carcinoma in situ of the breast or oral cavity or cervix are all permissible.
- •Patients with severe active co-morbidity.
- •Patients with psychiatric or addictive disorders that in the opinion of the investigator would preclude obtaining informed consent.
- •Patients who are pregnant or lactating.
- •Previous breast radiation on either side or thoracic radiation on the ipsilateral side.
研究者
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