NCT01394575Unknown2 期
Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Radiation toxicity
研究概览
简要总结
This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group performance score﹤2
- •All patients aged >18 years and < 70 years after breast conserving surgery.
- •On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- •Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS
- •No evidence of distant metastasis
- •Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins（>2mm）
- •Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical margins is permitted.
- •The patient must consent to be in the study and must have signed an approved consent form.
排除标准
- •Eastern Cooperative Oncology Group performance score≧2
- •Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- •Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated.
- •Metastatic disease (M1)
- •Pregnancy or lactating
- •Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
- •Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
- •Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- •Prior breast or thoracic RT for any condition.
- •Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
- •Synchronous chemotherapy or target therapy is not permitted.
- •Refusal of the patients to be included in the study
结局指标
主要结局
Radiation toxicity
时间窗: first analysis will occur 2 year after accrual of all patients
Cosmetic outcome
时间窗: first analysis will occur 2 year after accrual of all patients
次要结局
- Time to ipsilateral breast recurrence(first analysis will occur 5 year after accrual of all patients)
- Local recurrence rate(first analysis will occur 5 year after accrual of all patients)
- Disease free survival(first analysis will occur 5 year after accrual of all patients)
- Overall survival(first analysis will occur 5 year after accrual of all patients)
研究者
研究点 (1)
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