NCT00402519Unknown3 期
Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast
University of Erlangen-Nürnberg Medical School14 个研究点 分布在 5 个国家目标入组 1,300 人开始时间: 2004年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,300
- 试验地点
- 14
- 主要终点
- Local control
研究概览
简要总结
To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.
详细描述
To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 0, I or II breast cancer.
- •Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
- •Ductal carcinoma in situ (DCIS) alone.
- •No lymph invasion (L0) and no hemangiosis (V0).
- •Lesions of > 3 cm diameter, histopathologically confirmed.
- •pN0/pNmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of DCIS alone axillary staging (e.g. sentinel lymph node biopsy) is optional.
- •Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
- •For DCIS only: lesions must be classified as low or intermediate risk group (Van Nuys Prognostic Index <8).
- •Unifocal and unicentric DCIS or breast cancer.
- •Age >= 40 years.
- •Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
- •Signed study-specific consent form prior to randomization.
排除标准
- •Stage III or IV breast cancer.
- •Surgical margins that cannot be microscopically assessed.
- •Extensive intraductal component (EIC).
- •Paget's disease or pathological skin involvement.
- •Synchronous or previous breast cancer.
- •Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma FIGO 0 and I if patient is continuously disease-free.
- •Pregnant or lactating women.
- •Collagen vascular disease.
- •The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar.
- •Psychiatric disorders.
- •Patient with breast deemed technically unsatisfactory for brachytherapy.
结局指标
主要结局
Local control
时间窗: 5-years, 10 ten-years
次要结局
- Incidence and severity of acute and late side effects(5-years)
- Distant metastases free survival(5-years)
- Survival rates (Overall Survival, Disease-free Survival)(5-years)
- Differences in cosmetic results(5-years)
- Contralateral breast cancer rate(5-years)
- Quality-of-Life(5-years)
研究者
研究点 (14)
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