Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- local control rates
研究概览
简要总结
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.
详细描述
Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.
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
- 50 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 assured.
- •pN0 (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable).
- •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
- •Unifocal and unicentric DCIS or breast cancer.
- •Age > 50 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
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 International Federation of Gynecology and Obstetrics (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 telangiectatic or similar.
- •Psychiatric disorders.
- •Patient with breast deemed technically unsatisfactory for brachytherapy.
研究组 & 干预措施
Brachytherapy
Interstitial multicatheter brachytherapy
干预措施: Interstitial multicatheter brachytherapy (Radiation)
结局指标
主要结局
local control rates
时间窗: five years
次要结局
- late side effects(5 years)